DQI
9 FDA 510(k) clearances · Product code
146 daysmedian time to decision
266 days90th percentile
9clearances measured
FDA profile
- Official device name
- Withdrawal/Infusion Pump
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1800
- Medical specialty
- Cardiovascular
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1993: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| KSEA MODEL 383320 20 ANGIOMAT (K960486) | Karl Storz Endoscopy | 1996-10-25 |
| 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 |
Track DQI automatically
Every clearance here is in the API, with alerts when new ones post.