Steerable Catheter System

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K862424 ↗

FDA Product Code

GCP

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Oval Cup Biopsy Forcep

  Class II

  FDA 510(k) K911155 Active Cleared 7 Aug 1991

• Cleaning Brush

  Class I

  FDA 510(k) K874239 Active Cleared 29 Dec 1987

• Guide Wire

  Class I

  FDA 510(k) K874164 Active Cleared 7 Dec 1987

• Sheath, Endoscope

  Class II

  FDA 510(k) K862059 Active Cleared 4 Nov 1986

• Polypectomy Snare

  Class II

  FDA 510(k) K862060 Active Cleared 27 Jun 1986

• Endoscopic Retrograde Cholangiopancreatography

  Class II

  FDA 510(k) K860990 Active Cleared 13 May 1986

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• What is the Steerable Catheter System used for?

  The Steerable Catheter System is designed for endovascular procedures, providing selective cannulation of target vessels with challenging anatomy. It offers near 360-degree access to anatomy in three-dimensional space, giving vascular surgeons more control during procedures.

• How is the Steerable Catheter System supplied?

  The system is supplied as a single-use device and includes guiding catheters, guidewires, microcatheters, and support catheters that together determine reach, backup, and the ability to cross complex anatomy.

• What is the regulatory status of the Steerable Catheter System?

  The device is authorized under FDA 510K clearance with product code GCP and is classified as Class II. It is intended for use in gastroenterology and urology procedures.

• Is the Steerable Catheter System MRI safe?

  No, the Steerable Catheter System is not MRI safe. It is designed for use in standard endovascular procedures without MRI compatibility.