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Ranfac PIN-15 — single-use percutaneous introducer needle
FDA Cleared · K951090 Single Use · Sterile EO Latex-Free
General Surgery · Percutaneous Access

PIN-15 Percutaneous Introducer Needle

The PIN-15 is a single-use percutaneous introducer needle for guidewire placement and Seldinger-technique percutaneous access. Designed for controlled entry into vascular or hollow-organ targets prior to catheter or sheath placement.

CatalogPIN-15
Part #75010-01M
DeviceIntroducer Needle
TechniqueSeldinger / Percutaneous
SterilitySterile (EO)
ClearanceK951090

Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.

Overview

The Ranfac PIN-15 is a single-use percutaneous introducer needle for guidewire placement and Seldinger-technique percutaneous access. The device supports controlled needle entry into vascular or hollow-organ targets, followed by guidewire advancement and exchange for a catheter or sheath. Each device ships sterile, ethylene-oxide processed, and individually packaged.

The PIN-15 is the percutaneous-access device in the Ranfac surgical-instrument portfolio. Used as the first step of Seldinger-technique catheter or sheath placement in vascular, biliary, and urinary tract procedures. Pairs with the cholangiography catheters (LAP-13 port-access, XL-11 percutaneous) where biliary visualization is part of the procedure.

Clinical Applications

Refer to the device Instructions for Use for the full indications, contraindications, warnings, and procedure. The PIN-15 is intended for percutaneous access and guidewire placement during surgical and interventional procedures.

Practitioners use percutaneous introducer needles for vascular access, percutaneous biliary or urinary tract access, and other Seldinger-technique procedures where a needle precedes a guidewire and catheter. The PIN-15 supports standard guidewire diameters per the device IFU.

Vascular Access

Percutaneous arterial or venous entry prior to guidewire and catheter placement.

Interventional Radiology

Image-guided percutaneous access for diagnostic or therapeutic procedures.

Biliary & Urology

Percutaneous biliary tree or urinary tract access following Seldinger technique.

Standard MIS Workflows

Used across general, bariatric, gynecologic, and urologic laparoscopic procedures where the device is part of the surgeon's standard instrument set.

Specifications

PIN-15 Technical Data

Construction, regulatory, and packaging details. Gauge, length, cannula and stylet are listed in the hero above. For complete indications, contraindications, and warnings, download the Instructions for Use.

ConstructionStainless steel components · medical-grade polymer hub
ConnectionStandard luer connections per device IFU
SterilizationEthylene oxide · single-use · latex-free
PackagingIndividually pouched
FDA Clearance510(k) K951090 · Class II
PrescriptionRx only (21 CFR 801 Subpart D)

Directions for Use (Summary)

The following is a high-level summary. Refer to the device Instructions for Use for complete procedure, contraindications, and warnings.

  1. Inspect packaging. Confirm integrity; if undamaged, open using aseptic technique.
  2. Inspect the device. Verify needle integrity and stylet function prior to use.
  3. Identify the target by anatomy, palpation, or image guidance per protocol.
  4. Advance the needle into the target under controlled pressure and (if applicable) imaging.
  5. Confirm target entry by aspiration, fluoroscopy, or other modality per IFU.
  6. Remove the stylet and prepare for guidewire advancement.
  7. Advance the guidewire through the needle into the target.
  8. Withdraw the needle over the guidewire, holding the guidewire steady.
  9. Dispose in a sharps biohazard container per facility policy.

Documents & Downloads

Frequently Asked Questions

What is the PIN-15 used for?

Percutaneous access and guidewire placement during surgical and interventional procedures — most commonly as the first step of a Seldinger-technique catheter or sheath placement.

Is the PIN-15 FDA cleared?

Yes, under 510(k) K951090 as a Class II surgical instrument.

What guidewire sizes are compatible?

Refer to the device Instructions for Use for compatible guidewire diameters. The PIN-15 is intended for use with standard Seldinger-technique guidewires per IFU.

Is the device reusable?

No. The PIN-15 is a single-use device — supplied sterile and disposed of after a single procedure per facility policy.

What sterilization method is used?

Ethylene oxide (EO). The device is shipped sterile and is not made with natural rubber latex.

What guidewire diameters are compatible with the PIN-15?

The PIN-15 is intended for use with standard Seldinger-technique guidewires. For specific compatible diameters, refer to the device Instructions for Use.

Related Products

Other configurations in the Ranfac General Surgery family.

IN-12 — IN-12 Insufflation Needle (12 cm)

IN-12

Single-use 12 cm insufflation needle for laparoscopic pneumoperitoneum establishment

View →
RSG-14 — RSG-14 Puncture Closure Device

RSG-14

Single-use percutaneous puncture-closure device for laparoscopic trocar site management

View →
LAP-13 — LAP-13 Cholangiography Catheter (Port Access)

LAP-13

Single-use cholangiography catheter for laparoscopic intraoperative bile duct imaging via trocar port access

View →
XL-11 — XL-11 Cholangiography Catheter (Percutaneous Access)

XL-11

Single-use cholangiography catheter for percutaneous intraoperative bile duct imaging

View →

Order or Request a Sample of the PIN-15

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