BT715
BT715 is a medical device (FDA Class II; FDA product code CAC, Apparatus, Autotransfusion) made by Medtronic, Inc., cleared under FDA 510(k) K812292 on 23 Oct 1981 and listed in FDA GUDID since 9 Jun 2015 (UDI-DI 00613994744982), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00613994744982 | Date9 Jun 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK812292 | Date23 Oct 1981 | StatusActive |
Official records
- AccessGUDID record 00613994744982
- FDA 510(k) database K812292
Across registries
- FDA 510(k) K812292 decided 23 Oct 1981 Active
- FDA GUDID UDI-DI 00613994744982 listed 9 Jun 2015 Listed
Recalls
-
- Ongoing Z-0786-2019
Medtronic discovered that certain Y-connectors included in the suction lines have exhibited tearing and cracking. These defects could cause the Y-connectors to leak when in use, which could result in potential blood loss and a breach in the circuit.
Timeline
- Cleared FDA 510(k) K812292
- Listed FDA GUDID 00613994744982
- Recall initiated FDA recalls Z-0786-2019
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Autotransfusion system blood component processing set
- Model / reference
- BT715
- Primary DI / UDI-DI
- 00613994744982
- 510(k) Number
- FDA product code
- CAC
- GMDN term
- Autotransfusion system blood component processing set
- Device class
- Class II
- Regulation number
- 868.5830
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Autotransfusion system blood component processing set.