GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR
FDA 510(k) clearance K964973 · decided 1997-03-10
Clearance details
- K-number
- K964973
- Device name
- GISH CAP VRF45 CARDIOTOMY/VENOUS RESERVOIR
- Applicant
- Gish Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-12-12
- Decision date
- 1997-03-10
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- DTN
- Device class
- 2
- Regulation number
- 870.4400
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, 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.
| Record | Firm | Date |
|---|
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| MVR™ Venous Reservoir Bag 800 mL; MVR™ Venous Reservoir Bag 1600 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 800 mL; MVR™ Venous Reservoir Bag with Cortiva™ BioActive Surface 1600 mL (K241053) | Medtronic Cardiac Surgery | 2024-05-15 |
| BMR 1900 PHISIO (K223361) | Sorin Group Italia S.R.L. | 2023-06-10 |
| Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface (K170583) | Medtronic, Inc. | 2017-03-17 |
| INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C (K161733) | Sorin Group Italia S.R.L. | 2017-03-08 |
| Capiox Advance Hardshell Reservoir (K153143) | Terumo Cardiovascular Systems Corporation | 2015-12-02 |
| Intersept Filtered Cardiotomy Reservoir (K151110) | Medtronic, Inc. | 2015-05-27 |
| NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH (K141432) | Maquet Cardiopulmonary, AG | 2014-07-07 |
| AFFINITY PIXIE OXYGENATION SYSTEM WITH; CARMEDA BIOACTIVE SURFACE, BALANCE BIOSUFACE (K141233) | Medtronic, Inc. | 2014-06-12 |
| INITARY BETTER BLADDER-PEDIATRIC (K140321) | Circulatory Technology, Inc. | 2014-04-17 |
| VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT (K132166) | Maquet Cardiopulmonary, AG | 2013-10-30 |
Recalls involving this device
No recalls on record reference this clearance.