BD Trek Powered Bone Biopsy System
FDA 510(k) clearance K213896 · decided 2022-03-30
Clearance details
- K-number
- K213896
- Device name
- BD Trek Powered Bone Biopsy System
- Applicant
- Bard Peripheral Vascular
- Decision
- Substantially Equivalent
- Date received
- 2021-12-14
- Decision date
- 2022-03-30
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- KNW
- Device class
- 2
- Regulation number
- 876.1075
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Tempe, AZ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Flair Endovascular Stent Graft (P060002/S040) | Bard Peripheral Vascular | 2018-10-11 |
| FLAIR ENDOVASCULAR STENT GRAFT (P060002/S038) | Bard Peripheral Vascular | 2017-11-28 |
| Flair Endovascular Stent Graft (P060002/S039) | Bard Peripheral Vascular | 2017-07-19 |
| FLAIR ENDOVASCULAR STENT GRAFT (P060002/S036) | Bard Peripheral Vascular | 2016-05-16 |
| FLAIR ENDOVASCULAR STENT GRAFT (P060002/S034) | Bard Peripheral Vascular | 2014-08-13 |
| BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S035) | Bard Peripheral Vascular | 2014-04-23 |
| FLAIR ENDOVASCULAR STENT GRAFT (P060002/S033) | Bard Peripheral Vascular | 2013-09-16 |
| FLAIR ENDOVASCULAR STENT GRAFT (P060002/S032) | Bard Peripheral Vascular | 2013-05-29 |