COBE OPTIMIN HOLLOW FIBER MEMBRANE OXYGENATOR
FDA 510(k) clearance K991452 · decided 1999-10-07
Clearance details
- K-number
- K991452
- Device name
- COBE OPTIMIN HOLLOW FIBER MEMBRANE OXYGENATOR
- Applicant
- Cobe Cardiovascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-04-26
- Decision date
- 1999-10-07
- Days to decision
- 164 days
- Clearance type
- Traditional
- Product code
- DTZ
- Device class
- 2
- Regulation number
- 870.4350
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Arvada, CO, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Cobe Cardiovascular
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 |
|---|---|---|
| Cobe Optimin Hollow Fiber Sealed System, Oxygenator/Reservoir, Sterile, (Standalone system recall (Z-1424-06) | Cobe Cardiovascular, Inc | 2006-08-24 |
| Cobe Optimin Hollow Fiber Sealed System, Sterile, (Custom Heart / Lung Pack), Catalog Numb recall (Z-1427-06) | Cobe Cardiovascular, Inc | 2006-08-24 |