DWD · Suction Control, Intracardiac, Cardiopulmonary Bypass
Cardiovascular · 21 CFR 870.4430 · Class 2
Overview
| Product Code | DWD |
|---|---|
| Device Name | Suction Control, Intracardiac, Cardiopulmonary Bypass |
| Regulation | 21 CFR 870.4430 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
A cardiopulmonary bypass intracardiac suction control is a device which provides the vacuum and control for a cardiotomy return sucker.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Recent Cleared Devices (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K992657 | IBC VRV, MODEL 1350 | International Biophysics Corp. | Feb 18, 2000 | SESE |
| K920077 | NIKKISO NK PUMP | International Medical Products, Inc. | Sep 29, 1993 | SESE |
| K915482 | B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PT | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jan 7, 1992 | SESE |
| K915481 | B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINT | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jan 7, 1992 | SESE |
| K915480 | B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT. | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jan 7, 1992 | SESE |
| K905311 | DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD. | Baxter Bentley Laboratories, Inc. | Jan 15, 1991 | SESE |
| K895427 | MEDISEAL SUCTION CANISTER | Deroyal Industries, Inc. | Jan 19, 1990 | SESE |
| K864503 | MODIFIED RLV-2100 B | American Omni Medical, Inc. | Jan 6, 1987 | SESE |
| K863593 | SARNS SAFETY LOOP | 3M Health Care, Sarns | Nov 18, 1986 | SESE |
| K862540 | LEFT VENTRICULAR VENT VALVE MODEL NO. GLV | Gish Biomedical, Inc. | Aug 29, 1986 | SESE |
| K861428 | SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100 | American Omni Medical, Inc. | Jun 26, 1986 | SESE |
| K851406 | AJDJUSTABLE SUCTION CONTROL VALVE | American Omni Medical, Inc. | Aug 5, 1985 | SESE |
| K830150 | VEINPREP VEIN GRAFT PREP. KIT A277723 | Atrium Medical Corp. | Feb 28, 1983 | SESE |
| K830149 | IL VIDEO 22,21 & II ATOMIC SPECTROPHOTO- | Instrumentation Laboratory CO | Feb 28, 1983 | SESE |
| K760894 | VACUUM RELIEF VALVE | Delta Medical Industries | Dec 9, 1976 | SESE |
Top Applicants
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 3 clearances
- American Omni Medical, Inc. — 3 clearances
- International Medical Products, Inc. — 1 clearance
- International Biophysics Corp. — 1 clearance
- Instrumentation Laboratory CO — 1 clearance
