BT133
BT133 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 17 Jun 2015 (UDI-DI 00673978522241), active as of 22 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 | Number00673978522241 | Date17 Jun 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK812292 | Date23 Oct 1981 | StatusActive |
Official records
- AccessGUDID record 00673978522241
- FDA 510(k) database K812292
Across registries
- FDA 510(k) K812292 decided 23 Oct 1981 Active
- FDA GUDID UDI-DI 00673978522241 listed 17 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 00673978522241
- 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- Withdrawn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
- BT133
- Primary DI / UDI-DI
- 00673978522241
- 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.