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# Guide on PTA and Specialty Catheter 510(k)s
- URL: https://www.fdaweb.com/guide-on-pta-and-specialty-catheter-510-k-s/
- Published: 2020-01-10T12:00:00.000Z
- Updated: 2026-09-14T15:58:19.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145815

FDA has released a [draft guidance](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/peripheral-percutaneous-transluminal-angioplasty-pta-and-specialty-catheters-premarket-notification?ref=fdaweb.com) on “Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters – Premarket Notification (510(k)) Submissions.” The document provides draft recommendations, including bench testing and coating characterizations for 510(k) submissions for PTA balloons and specialty catheters (e.g., infusion catheters, PTA balloon catheters for in-stent restenosis, scoring/cutting balloons). It provides anatomy-specific testing recommendations and expands on FDA’s current thinking for testing of these devices.

Additionally, the guidance covers non-clinical performance testing, including bench testing and animal testing for such devices. It also addresses device labeling and device modifications.