AC4006
AC4006 is a Class II device made by Medtronic, Inc., cleared under FDA 510(k) K945461 on 3 Feb 1995 and listed in FDA GUDID since 2 Oct 2016 (UDI-DI 00643169002968), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00643169002968 | Date2 Oct 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK945461 | Date3 Feb 1995 | StatusActive |
Official records
- AccessGUDID record 00643169002968
- FDA 510(k) database K945461
Across registries
- FDA 510(k) K945461 decided 3 Feb 1995 Active
- FDA GUDID UDI-DI 00643169002968 listed 2 Oct 2016 Listed
Timeline
- Cleared FDA 510(k) K945461
- Listed FDA GUDID 00643169002968
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Torque manipulation device
- Model / reference
- AC4006
- Primary DI / UDI-DI
- 00643169002968
- 510(k) Number
- FDA product code
- DTL
- GMDN term
- Torque manipulation device
- Device class
- Class II
- Regulation number
- 870.4290
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code DTL (Adaptor, stopcock, manifold, fitting, cardiopulmonary bypass).
- Manifold 193111 by Argon Medical Devices, Inc.
- Contrast Line 193382 by Argon Medical Devices, Inc.
- Demax DHDT03B by Beijing Demax Medical Technology Co., Ltd.
- Merit® Manifold 00884450022979 by Merit Medical Systems, Inc.
- Demax DHDY01B by Beijing Demax Medical Technology Co., Ltd.
- PITON(TM) Y-PACK AND PITON(TM) TRI-PACK) by Medtronics Interventional Vascular
- Medi-Plast 2 Port Manifold (Right On) by Medi-Plast Intl., Inc.
- Merit® Manifold 00884450034101 by Merit Medical Systems, Inc.
- Cardioplegia Delivery Sets With Duraflo Coating by Edwards Lifesciences LLC
- Manifold by Medical Specialties Intl., Inc.