CARDIO-PAK ANGIOGRAPHY CUSTOM PACKS
FDA 510(k) clearance K902475 · decided 1990-12-03
Clearance details
- K-number
- K902475
- Device name
- CARDIO-PAK ANGIOGRAPHY CUSTOM PACKS
- Applicant
- Cardio-Pak
- Decision
- Substantially Equivalent
- Date received
- 1990-06-04
- Decision date
- 1990-12-03
- Days to decision
- 182 days
- Clearance type
- Traditional
- Product code
- DXT
- Device class
- 2
- Regulation number
- 870.1650
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Billings, MT, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cardio-Pak
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 |
|---|---|---|
| Custom surgical packs for a variety of surgical applications. Each pack is custom assemble recall (Z-0753-03) | Windstone Medical, Inc. | 2003-04-22 |