510(k) K960486
- Device
- KSEA MODEL 383320 20 ANGIOMAT
- Applicant
- KARL STORZ ENDOSCOPY
- 510(k) number
- K960486
- Product code
- DQI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-10-25
- Date received
- 1996-02-02
- Regulation
- 870.1800
- Classification name
- Withdrawal/infusion Pump
- Medical specialty
- Cardiovascular
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RENATE A MACLAREN
- Address
- 600 Corporate Pt.e Culver City CA US 90230 90230
FDA Registration Numbers#
- 3013247477
- 2020550
- 3010202439
Source Documents#
Other 510(k) Records For Product Code DQI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K935763 | SURGIPUMP | W.O.M. World of Medicine GmbH | 1994-04-21 |
| K922541 | USCI SUPER 9 PTCA GUIDING CATHETER | C.R. Bard, Inc. | 1992-12-08 |
| K924110 | LEOCOR CORFLO PUMP -- MODIFICATION | Leocor, Inc. | 1992-09-01 |
| K905189 | BAXTER ANGIOSCOPY PUMP TUBING SET (MODEL NL) | Baxter Healthcare Corp | 1991-01-30 |
| K902444 | CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP | Intramed Laboratories, Inc. | 1990-08-30 |
| K895688 | NOBLES-LAI ENGINEERING INFUSION PUMP | Nobles-Lai Engineering, Inc. | 1990-02-26 |
| K895074 | ANGIOSCOPY PUMP | Baxter Healthcare Corp | 1990-01-31 |
| K871422 | OLYMPUS ANGIOSCOPY PUMP | Olympus Corp. | 1987-08-12 |
Legacy Summary#
summary
FDA Review#
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