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Amer Ed Labs Ptca

FDA PMA

Class II (US FDA PMA)

PMA P850021

by Abbott Vascular Inc.

Identity

Trade Name
AMER, ED. LABS. PTCA FDA PMA
Generic Name
Catheters, transluminal coronary angioplasty, percutaneous FDA PMA

Identifiers

PMA Number
P850021 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

This device is a Catheter, Transluminal Coronary Angioplasty, Percutaneous, designed for use in percutaneous transluminal coronary angioplasty (PTCA) procedures. It is intended to dilate narrowed or obstructed coronary arteries to restore blood flow, improving myocardial perfusion in patients with coronary artery disease.

The catheter is supplied as a single-use device and is regulated under FDA Premarket Approval (PMA) with the designation P850021. It is classified under product code LOX and adheres to regulation number 870.5100. The device is intended for use in controlled clinical settings, such as cardiac catheterization labs, and requires proper sterilization and storage as specified by the manufacturer.

Frequently asked questions

What is the primary clinical purpose of the AMER, ED. LABS. PTCA catheter, and where is it typically used?

The AMER, ED. LABS. PTCA catheter is designed specifically for percutaneous transluminal coronary angioplasty (PTCA), a procedure to dilate narrowed or obstructed coronary arteries. This improves blood flow to the heart muscle (myocardial perfusion) in patients with coronary artery disease. It is intended for use exclusively in controlled clinical settings, such as cardiac catheterization labs, where specialized equipment and trained personnel can perform the procedure safely.

Is the AMER, ED. LABS. PTCA catheter intended for single-use or repeated use, and how should it be handled?

The AMER, ED. LABS. PTCA catheter is supplied as a single-use device, meaning it is not meant for reuse after a single procedure. Proper sterilization and storage instructions must be followed as directed by the manufacturer to ensure device integrity and patient safety before use.

What regulatory pathway does the AMER, ED. LABS. PTCA catheter follow, and what does this mean for its use?

The AMER, ED. LABS. PTCA catheter is regulated under the FDA Premarket Approval (PMA) pathway, with the approval number P850021. This means it has undergone rigorous clinical evaluation to demonstrate safety and effectiveness before being authorized for commercial distribution. Its use is governed by the FDA’s PMA requirements, ensuring it meets stringent standards for coronary angioplasty devices.

Does the AMER, ED. LABS. PTCA catheter come in multiple sizes or models, and if so, how would a clinician determine the appropriate one?

While the provided data does not specify exact sizes or models of the AMER, ED. LABS. PTCA catheter, it is classified under product code LOX and falls under the FDA’s Category II device classification for transluminal coronary angioplasty catheters. Clinicians would typically select the appropriate size based on patient anatomy, lesion characteristics, and procedural requirements, following manufacturer guidelines or institutional protocols for PTCA catheter selection.

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. Sources consulted: AMER, ED. LABS. PTCA (P850021) — FDA 510 (k) | Innolitics, Amer, Ed. Labs. Ptca PMA P850021S008 - FDA.report, Abbott Vascular, Inc. FDA 510 (k) Products (2000-2014), Abbott Vascular, Inc. Medical Devices | MedTracker, Abbott Vascular, Inc. FDA 510 (k) Products (2000-2014)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_PMA

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Manufacturer

Manufacturer
Abbott Vascular Inc.
FDA Applicant
Abbott Vascular, Inc.

Sources (1)

  • FDA PMA P850021 24 fields · synced Sep 18, 2026