Percutaneus Transluminal Coronary Angioplasty Cath

No FDA recalls found in the data synced 22 Oct 2026.

Generic Name

Catheters, transluminal coronary angioplasty, percutaneous

PMA Number

P940009 ↗

FDA Product Code

LOX

Device Class

Class II

Regulation

21 CFR Part 870.5100

Advisory Committee

Cardiovascular

FDA Decision

APRL

• Triguide Guide Catheters

  Class II

  FDA 510(k) K953515 Active Cleared 19 Sep 1995

• Scimed Viper

  Class II

  FDA 510(k) K933183 Active Cleared 9 Sep 1993

• Scimed 7Fr and 8Fr Triguide Guiding Catheters

  Class II

  FDA 510(k) K914312 Active Cleared 22 Nov 1991

• Scimed Triguide Guide Catheter

  Class II

  FDA 510(k) K944537 Active Cleared 21 Oct 1994

• Scimed Pursuit Exchange Ptca Guide Wire

  Class II

  FDA 510(k) K945159 Active Cleared 30 Dec 1994

• Scimed(R) Controlwire(Tm) Guide Wire

  Class II

  FDA 510(k) K914194 Active Cleared 9 Jun 1992

See all devices from Scimed Life Systems, Inc. →

• What is the primary purpose of this catheter in a clinical setting?

  This catheter is specifically designed for percutaneous coronary intervention (PCI), where it mechanically dilates narrowed or obstructed coronary arteries to restore blood flow. It is used during balloon angioplasty procedures to widen stenotic segments within coronary vessels, ensuring proper function of the heart’s blood supply.

• Is this device intended for reuse, or is it single-use only?

  The device is strictly single-use only. The manufacturer emphasizes sterility and proper handling, as reuse is not intended and could compromise patient safety. Each catheter is meant for one-time use in a controlled clinical setting.

• What regulatory pathway does this device follow, and how was it approved?

  This device follows the FDA Premarket Approval (PMA) pathway, with the approval number P940009. It was reviewed by the Cardiovascular (CV) Advisory Committee and received approval on September 29, 1994, after a formal submission process. The device is classified as Class II under regulation number 870.5100 and is intended for use in specialized cardiac catheterization labs.

• Are there different sizes or models available for this catheter?

  While the provided data does not specify exact sizes or model variations, the OpenFDA registration numbers indicate multiple FEI (Final Establishment Identification) numbers, suggesting that different catheter variants (e.g., diameters, lengths, or balloon sizes) may exist. For precise sizing details, consulting the manufacturer’s catalog or technical documentation is recommended.

• How should this catheter be stored to maintain its integrity?

  Since this is a single-use, sterile device, it should be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The manufacturer’s instructions (not provided here) should be followed for specific storage conditions, but generally, maintaining sterility and preventing contamination are critical to ensure proper functionality before use.