Baxter Angioscopy Pump Tubing Set (Model NL)
FDA 510(k) K905189 · Baxter Healthcare Corp
510(k) numberK905189
Submission
- Device name
- Baxter Angioscopy Pump Tubing Set (Model NL)
- Applicant
- Baxter Healthcare Corp
Santa Ana, CA, US - Received
- November 19, 1990
- Decision date
- January 30, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQI – Withdrawal/Infusion Pump
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1800
- Specialty
- Cardiovascular
Other 510(k)s with product code DQI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K960486 | Ksea Model 383320 20 AngiomatDQI · Traditional | Karl Storz Endoscopy | 10/25/1996SE |
| K935763 | SurgipumpDQI · Traditional | W.O.M. World of Medicine GmbH | 04/21/1994SE |
| K922541 | Usci Super 9 Ptca Guiding CatheterDQI · Traditional | C.R. Bard, Inc. | 12/08/1992SE |
| K924110 | Leocor Corflo Pump -- ModificationDQI · Traditional | Leocor, Inc. | 09/01/1992SE |
| K902444 | Clearview(Tm) Angioscopic Irrigation PumpDQI · Traditional | Intramed Laboratories, Inc. | 08/30/1990SE |
| K895688 | Nobles-Lai Engineering Infusion PumpDQI · Traditional | Nobles-Lai Engineering, Inc. | 02/26/1990SE |
| K895074 | Angioscopy PumpDQI · Traditional | Baxter Healthcare Corp | 01/31/1990SE |
| K871422 | Olympus Angioscopy PumpDQI · Traditional | Olympus Corp. | 08/12/1987SE |
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Questions and answers
When was Baxter Angioscopy Pump Tubing Set (Model NL) cleared by the FDA?
Baxter Angioscopy Pump Tubing Set (Model NL) (K905189) received a 510(k) decision of Substantially Equivalent on January 30, 1991, 72 days after the submission was received.
What is the product code of K905189?
The FDA product code is DQI – Withdrawal/Infusion Pump, a Class II (moderate risk) device regulated under 21 CFR 870.1800.