# Cardiovascular Devices; Reclassification of Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters
> **Food and Drug Administration** · Final rule. · Published 2010-09-08 · Effective 2010-10-08 · 75 FR 54493
## Document
- **Document number:** 2010-22304
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 75 FR 54493
- **CFR reference:** 21 CFR 870
- **Publication date:** 2010-09-08
- **Effective date:** 2010-10-08
- **HHS docket:** Docket No. FDA-2000-P-0924
## Abstract

The Food and Drug Administration (FDA) is reclassifying the device type, standard percutaneous transluminal coronary angioplasty (PTCA) catheters, from class III (premarket approval) into class II (special controls). Cutting/scoring PTCA catheters remain in class III and continue to require premarket approval applications (PMAs). FDA is reclassifying these devices in accordance with the Federal Food, Drug, and Cosmetic Act (the act). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters" that will serve as the special control for the reclassified device type.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2010/09/08/2010-22304/cardiovascular-devices-reclassification-of-certain-percutaneous-transluminal-coronary-angioplasty)
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