Cook MBC PTCA Balloon Dilatation Catheter
FDA PMAClass II (US FDA PMA)
by Cook, Inc.
Identity
- Trade Name
- COOK MBC PTCA BALLOON DILATATION CATHETER FDA PMA
- Generic Name
- Catheters, transluminal coronary angioplasty, percutaneous FDA PMA
Identifiers
- PMA Number
- P990008 FDA PMA
- FDA Product Code
- LOX FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 870.5100 FDA PMA
- Regulation Number
- 870.5100 FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APWD FDA PMA
The Cook MBC PTCA Balloon Dilatation Catheter is a catheter, transluminal coronary angioplasty, percutaneous, designed for balloon dilatation of hemodynamically significant coronary artery or bypass graft stenosis. It is intended to improve myocardial perfusion in patients experiencing coronary ischemia by mechanically widening narrowed vessels.
This device is supplied as a single-use, non-sterile catheter and is regulated under FDA Premarket Approval (PMA P990008). It is intended for use in interventional cardiology procedures, typically within a catheterization laboratory setting. The device adheres to regulatory classification 870.5100 and is manufactured by Cook, Inc. in Bloomington, Indiana.
Frequently asked questions
What is the primary clinical purpose of the Cook MBC PTCA Balloon Dilatation Catheter, and where is it typically used?
The Cook MBC PTCA Balloon Dilatation Catheter is designed to mechanically widen narrowed coronary arteries or bypass grafts to improve blood flow in patients experiencing coronary ischemia. It is specifically intended for use in interventional cardiology procedures, such as percutaneous transluminal coronary angioplasty (PTCA), and is typically deployed within a catheterization laboratory setting.
Is the Cook MBC PTCA Balloon Dilatation Catheter intended for single-use or repeated use, and what is its sterility status?
The device is explicitly supplied as a single-use catheter and is non-sterile. This means it is intended for one-time use in a single patient procedure, and sterilization procedures are not applicable or recommended for reuse.
What regulatory pathway was followed for the approval of this device, and what does that mean for its use?
The Cook MBC PTCA Balloon Dilatation Catheter was approved through the FDA’s Premarket Approval (PMA) process, specifically under PMA number P990008. This pathway is used for higher-risk devices, ensuring rigorous evaluation of safety and effectiveness before market authorization. The approval confirms the device meets FDA standards for use in balloon dilatation of hemodynamically significant coronary artery or bypass graft stenosis.
What sizes or models of the Cook MBC PTCA Balloon Dilatation Catheter are available, and how would I identify them?
The exact sizes of the Cook MBC PTCA Balloon Dilatation Catheter are not detailed in the provided data, but the device is listed under multiple registration numbers (e.g., 3015002281, 3002095335) and product codes (LOX), which may correspond to different models or diameters. For precise sizing information, refer to the manufacturer’s packaging or accompanying documentation, as these details are critical for selecting the appropriate catheter for a patient’s specific coronary anatomy.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P990008 | Class II | Active |
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Manufacturer
- Manufacturer
- Cook, Inc.
Sources (1)
- FDA PMA P990008 24 fields · synced Sep 18, 2026