Adi Catheter with Valve
by Asia Dynamics, Inc. 510(k)
Active
510(k) K952924
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK952924 | Date18 Aug 1995 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- GBM
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5130
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent