TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221
FDA 510(k) clearance K052570 · decided 2006-01-17
Clearance details
- K-number
- K052570
- Device name
- TANDEMHEART TRANSSEPTAL CANNULA SET-EF, MODEL 5140-6221
- Applicant
- Cardiacassist, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-09-19
- Decision date
- 2006-01-17
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Pittsburgh, PA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cardiacassist
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TandemHeart Transseptal Cannulas-EF set (THTC-EF) - Dilator assembly The TandemHeart Trans recall (Z-0889-2011) | Cardiac Assist, Inc | 2011-01-10 |