Atlas FDA

DWD

15 FDA 510(k) clearances · Product code

53 daysmedian time to decision
193 days90th percentile
15clearances measured

FDA profile

Official device name
Suction Control, Intracardiac, Cardiopulmonary Bypass
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4430
Medical specialty
Cardiovascular
Adverse events (MAUDE)
2008: 2 · 2013: 10 · 2014: 7 · 2015: 38 · 2017: 12 · 2019: 13
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
IBC VRV, MODEL 1350 (K992657)International Biophysics Corp.2000-02-18
NIKKISO NK PUMP (K920077)International Medical Products, Inc.1993-09-29
B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT. (K915480)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-01-07
B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINT (K915481)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-01-07
B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PT (K915482)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-01-07
DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD. (K905311)Baxter Bentley Laboratories, Inc.1991-01-15
MEDISEAL SUCTION CANISTER (K895427)Deroyal Industries, Inc.1990-01-19
MODIFIED RLV-2100 B (K864503)American Omni Medical, Inc.1987-01-06
SARNS SAFETY LOOP (K863593)3M Health Care, Sarns1986-11-18
LEFT VENTRICULAR VENT VALVE MODEL NO. GLV (K862540)Gish Biomedical, Inc.1986-08-29
SUCTION CONTROL VALVE (NONADJUSTABLE) CAT.RLV-2100 (K861428)American Omni Medical, Inc.1986-06-26
AJDJUSTABLE SUCTION CONTROL VALVE (K851406)American Omni Medical, Inc.1985-08-05
IL VIDEO 22,21 & II ATOMIC SPECTROPHOTO- (K830149)Instrumentation Laboratory CO1983-02-28
VEINPREP VEIN GRAFT PREP. KIT A277723 (K830150)Atrium Medical Corp.1983-02-28
VACUUM RELIEF VALVE (K760894)Delta Medical Industries1976-12-09

Track DWD automatically

Every clearance here is in the API, with alerts when new ones post.