Suction Control, Intracardiac, Cardiopulmonary Bypass
The Cardiopulmonary Bypass Intracardiac Suction Control is a cardiovascular device used to manage and regulate suction applied within the heart chambers during open-heart surgery, aspirating blood and debris to maintain a clear operative field. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DWD and it is regulated under 21 CFR 870.4430 within the Cardiovascular medical specialty.
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Basic Information
- Product Code
- DWD
- Device Class
- FDA class 2
- Regulation Number
- 870.4430
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 15 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K992657 | IBC VRV, MODEL 1350 | Feb 18, 2000 | Substantially Equivalent | International Biophysics Corp. |
| K920077 | NIKKISO NK PUMP | Sep 29, 1993 | Substantially Equivalent | International Medical Products, Inc. |
| K915482 | B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PT | Jan 07, 1992 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K915481 | B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINT | Jan 07, 1992 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K915480 | B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT. | Jan 07, 1992 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K905311 | DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD. | Jan 15, 1991 | Substantially Equivalent | Baxter Bentley Laboratories, Inc. |
| K895427 | MEDISEAL SUCTION CANISTER | Jan 19, 1990 | Substantially Equivalent | Deroyal Industries, Inc. |
| K864503 | MODIFIED RLV-2100 B | Jan 06, 1987 | Substantially Equivalent | American Omni Medical, Inc. |
| K863593 | SARNS SAFETY LOOP | Nov 18, 1986 | Substantially Equivalent | 3M Health Care, Sarns |
| K862540 | LEFT VENTRICULAR VENT VALVE MODEL NO. GLV | Aug 29, 1986 | Substantially Equivalent | Gish Biomedical, Inc. |
| K861428 | SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100 | Jun 26, 1986 | Substantially Equivalent | American Omni Medical, Inc. |
| K851406 | AJDJUSTABLE SUCTION CONTROL VALVE | Aug 05, 1985 | Substantially Equivalent | American Omni Medical, Inc. |
| K830150 | VEINPREP VEIN GRAFT PREP. KIT A277723 | Feb 28, 1983 | Substantially Equivalent | Atrium Medical Corp. |
| K830149 | IL VIDEO 22,21 & II ATOMIC SPECTROPHOTO- | Feb 28, 1983 | Substantially Equivalent | Instrumentation Laboratory CO |
| K760894 | VACUUM RELIEF VALVE | Dec 09, 1976 | Substantially Equivalent | Delta Medical Industries |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.