Withdrawal/Infusion Pump
The Withdrawal/Infusion Pump is a cardiovascular device used to withdraw blood samples or infuse fluids at controlled rates during diagnostic or therapeutic cardiovascular procedures. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DQI and it is regulated under 21 CFR 870.1800 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- DQI
- Device Class
- FDA class 2
- Regulation Number
- 870.1800
- Medical Specialty
- Cardiovascular
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K960486 | KSEA MODEL 383320 20 ANGIOMAT | Oct 25, 1996 | Substantially Equivalent | Karl Storz Endoscopy |
| K935763 | SURGIPUMP | Apr 21, 1994 | Substantially Equivalent | W.O.M. World of Medicine GmbH |
| K922541 | USCI SUPER 9 PTCA GUIDING CATHETER | Dec 08, 1992 | Substantially Equivalent | C.R. Bard, Inc. |
| K924110 | LEOCOR CORFLO PUMP -- MODIFICATION | Sep 01, 1992 | Substantially Equivalent | Leocor, Inc. |
| K905189 | BAXTER ANGIOSCOPY PUMP TUBING SET (MODEL NL) | Jan 30, 1991 | Substantially Equivalent | Baxter Healthcare Corp |
| K902444 | CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP | Aug 30, 1990 | Substantially Equivalent | Intramed Laboratories, Inc. |
| K895688 | NOBLES-LAI ENGINEERING INFUSION PUMP | Feb 26, 1990 | Substantially Equivalent | Nobles-Lai Engineering, Inc. |
| K895074 | ANGIOSCOPY PUMP | Jan 31, 1990 | Substantially Equivalent | Baxter Healthcare Corp |
| K871422 | OLYMPUS ANGIOSCOPY PUMP | Aug 12, 1987 | Substantially Equivalent | Olympus Corp. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.