Versaflex Buchbinder Omniflex PTCA Catheter System

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

Trade Name

Medtronic(R) MS2(Tm) Balloon Shaping Tool

Generic Name

Catheters, transluminal coronary angioplasty, percutaneous

PMA Number

P870036 ↗

FDA Product Code

LOX

Device Class

Class II

Regulation

21 CFR Part 870.5100

Advisory Committee

Cardiovascular

FDA Decision

APPR Approved

PMA Supplement

S042

• Gc IV Coronary Guiding Catheter

  Class II

  FDA 510(k) K932933 Active Cleared 1 Feb 1994

• Medtronic 7F and 8F Zuma Guiding Catheter

  Class II

  FDA 510(k) K982883 Active Cleared 4 Sep 1998

• Medtronic Interventional Vascular Y-Adapter, Tri-Adapter, Tri-Adapter & Accessory Packs

  Class II

  FDA 510(k) K940063 Active Cleared 29 Mar 1994

• Medtronic(R) 8.2 French Sherpa(R) Super Peak Flow(Tm) Coronary Guiding Catheter

  Class II

  FDA 510(k) K950026 Active Cleared 5 Apr 1995

• Sherpa Sherpa II and Ascent Coronary Guiding Catheters

  Class II

  FDA 510(k) K944668 Active Cleared 3 Mar 1995

• Medtronic Gciii Coronary Guiding Catheter

  Class II

  FDA 510(k) K935738 Active Cleared 4 May 1994

See all devices from Medtronics Interventional Vascular →

• What clinical procedure is the Versaflex Buchbinder Omniflex PTCA Catheter System designed for, and how does it function?

  The Versaflex Buchbinder Omniflex PTCA Catheter System is specifically designed for percutaneous transluminal coronary angioplasty (PTCA), a procedure used to mechanically dilate narrowed or obstructed coronary arteries. It achieves this by inflating a balloon at its distal end under fluoroscopic guidance, which expands the artery and restores blood flow to improve myocardial perfusion.

• Is this catheter system single-use or reusable, and what does that mean for clinical workflow?

  The Versaflex Buchbinder Omniflex PTCA Catheter System is sterile and single-use only, meaning each catheter is intended for one procedure and must not be reused. This ensures patient safety by eliminating cross-contamination risks and simplifies clinical workflow by avoiding reprocessing steps.

• What sizes and configurations are available for this catheter system, and how might that affect my selection?

  The system comes in multiple configurations, including 18K, 18K with Tip Marker, 14K, 14K Long, Panther 30, and 40. These variations allow clinicians to choose based on the specific anatomy, lesion type, or procedural requirements—such as longer catheters for complex cases or specific shaft profiles for better maneuverability.

• Can this catheter be used with MRI-safe imaging equipment, and are there any special considerations?

  Yes, the Versaflex Buchbinder Omniflex PTCA Catheter System is non-magnetic and compatible with MRI-safe imaging equipment. However, it must still be used in accordance with established clinical protocols, as the balloon inflation and other procedural steps remain subject to standard safety guidelines for PTCA.

• How is the regulatory approval status of this device relevant to my purchase or use?

  The device holds FDA Premarket Approval (PMA P870036), which confirms it meets rigorous standards for safety and effectiveness as a Catheter, Transluminal Coronary Angioplasty, Percutaneous. This approval ensures compliance with U.S. regulatory requirements, though actual use must align with the labeled indications and clinical protocols provided by the manufacturer.