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GUIDANCE DOCUMENT

Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions Guidance for Industry and Food and Drug Administration Staff January 2020

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-D-5422


Docket Number:
FDA-2019-D-5422
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

This draft guidance document provides draft recommendations, including bench testing and coating characterizations for 510(k) submissions for peripheral percutaneous transluminal angioplasty (PTA) balloons and specialty catheters (e.g., infusion catheters, PTA balloon catheters for in-stent restenosis (ISR), scoring/cutting balloons). These devices are catheter-based devices intended to treat lesions in the peripheral vasculature. This document provides anatomy-specific testing recommendations and expands on FDA’s current thinking for testing of these devices. FDA is issuing this draft guidance to clarify FDA’s premarket submission recommendations for PTA catheters and specialty catheters and to promote consistency across submissions.