Forgarty Chin Peripheral Intraoperative
by American Edwards Laboratories 510(k)
Active
510(k) K830733
Overview
The Forgarty Chin Peripheral Intraoperative is a catheter used for peripheral angioplasty procedures. It is designed for intraoperative use in peripheral vascular interventions.
This device is manufactured by American Edwards Laboratories and is a Class II medical device. It received FDA 510(k) clearance in 1983 with product code LIT and is intended for cardiovascular procedures.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK830733 | Date18 Apr 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- LIT
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1250
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent