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# Draft Guide on PTA/Specialty Catheters
- URL: https://www.fdaweb.com/draft-guide-on-pta-specialty-catheters/
- Published: 2020-01-13T12:00:00.000Z
- Updated: 2026-09-14T15:58:26.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145826

*Federal Register* notice: FDA has made available a draft guidance entitled “Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters — Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff.” The document applies to infusion catheters, PTA balloon catheters for in-stent restenosis, and scoring/cutting balloons. It covers bench testing and coating characterizations for 510(k) submissions for such devices. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-01-13/pdf/2020-00296.pdf?ref=fdaweb.com).