KSEA MODEL 383320 20 ANGIOMAT
FDA 510(k) clearance K960486 · decided 1996-10-25
Clearance details
- K-number
- K960486
- Device name
- KSEA MODEL 383320 20 ANGIOMAT
- Applicant
- Karl Storz Endoscopy
- Decision
- Substantially Equivalent
- Date received
- 1996-02-02
- Decision date
- 1996-10-25
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- DQI
- Device class
- 2
- Regulation number
- 870.1800
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Culver City, 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 |
|---|---|---|
| SURGIPUMP (K935763) | W.O.M. World of Medicine GmbH | 1994-04-21 |
| USCI SUPER 9 PTCA GUIDING CATHETER (K922541) | C.R. Bard, Inc. | 1992-12-08 |
| LEOCOR CORFLO PUMP -- MODIFICATION (K924110) | Leocor, Inc. | 1992-09-01 |
| BAXTER ANGIOSCOPY PUMP TUBING SET (MODEL NL) (K905189) | Baxter Healthcare Corp | 1991-01-30 |
| CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP (K902444) | Intramed Laboratories, Inc. | 1990-08-30 |
| NOBLES-LAI ENGINEERING INFUSION PUMP (K895688) | Nobles-Lai Engineering, Inc. | 1990-02-26 |
| ANGIOSCOPY PUMP (K895074) | Baxter Healthcare Corp | 1990-01-31 |
| OLYMPUS ANGIOSCOPY PUMP (K871422) | Olympus Corp. | 1987-08-12 |
Recalls involving this device
No recalls on record reference this clearance.