Leocor Corflo Model 7.5PT PTCA Catheter

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

Full name

Leocor Corflo(Tm) Model 7.5PT Ptca Catheter

Trade Name

Leocor,inc. Models 1

Generic Name

Catheters, transluminal coronary angioplasty, percutaneous

PMA Number

P890001 ↗

FDA Product Code

LOX

Device Class

Class II

Regulation

21 CFR Part 870.5100

Advisory Committee

Cardiovascular

FDA Decision

APPR Approved

• Leocor Guiding Catheter

  Class II

  FDA 510(k) K911270 Active Cleared 17 Jan 1992

• Leocor Corflo Pump -- Modification

  Class II

  FDA 510(k) K924110 Active Cleared 1 Sep 1992

• Leocor Corflo(Tm) Pump

  Class II

  FDA 510(k) K900350 Active Cleared 17 Jul 1990

• What is the primary clinical purpose of the Leocor Corflo Model 7.5PT PTCA Catheter, and where would it typically be used?

  The Leocor Corflo Model 7.5PT PTCA Catheter is specifically designed for percutaneous transluminal coronary angioplasty (PTCA), a procedure to widen narrowed or blocked coronary arteries. It achieves this by inflating a balloon at the catheter tip, restoring blood flow to the affected area. This device is intended for use in controlled clinical settings, such as cardiac catheterization labs, where interventional cardiologists perform coronary artery interventions.

• Is the Leocor Corflo Model 7.5PT PTCA Catheter intended for reuse, or is it single-use only?

  The device is explicitly labeled as single-use only, meaning it is not designed for reuse after a single procedure. This ensures patient safety and sterility, as reuse could compromise the device’s integrity and introduce infection risks.

• How should the Leocor Corflo Model 7.5PT PTCA Catheter be stored to maintain its sterility and functionality?

  The manufacturer instructs that the device must be stored in accordance with their specific guidelines to preserve sterility and functionality. While the exact storage conditions (e.g., temperature, packaging) aren’t detailed here, standard practice for single-use catheters typically involves keeping them in their original, sealed packaging in a clean, dry environment away from direct sunlight or extreme temperatures until use.

• What regulatory pathway was followed for the approval of this device, and what classification does it hold?

  The Leocor Corflo Model 7.5PT PTCA Catheter was approved through the FDA’s Premarket Approval (PMA) process, with approval granted under PMA number P890001. It is classified as a Class II medical device under regulation number 870.5100, indicating it requires a higher level of scrutiny due to its role in life-sustaining or life-supporting procedures.