COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR
FDA 510(k) clearance K963518 · decided 1997-12-08
Clearance details
- K-number
- K963518
- Device name
- COBE OPTIMA XP HOLLOW FIBER MEMBRANE OXYGENATOR
- Applicant
- Cobe Cardiovascular, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-09-03
- Decision date
- 1997-12-08
- Days to decision
- 461 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 CML Duo Flat Sheet Membrane Oxygenator/Reservoir, sterile, (Standalone systems). Cata recall (Z-1423-06) | Cobe Cardiovascular, Inc | 2006-08-24 |
| Cobe CML Duo Flat Sheet Membrane Oxygenator, sterile, (Custom Heart/Lung Packs), Catalog n recall (Z-1426-06) | Cobe Cardiovascular, Inc | 2006-08-24 |