Atlas FDA

KRI

42 FDA 510(k) clearances · Product code

52 daysmedian time to decision
136 days90th percentile
42clearances measured

FDA profile

Official device name
Accessory Equipment, Cardiopulmonary Bypass
Device class
Class I (low risk)
Regulation
21 CFR 870.4200
Medical specialty
Cardiovascular
Adverse events (MAUDE)
1996: 2 · 2003: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE (K020365)3t Medical Systems, LLC2002-05-03
INTERFACE MODULE IDDD (K992635)Stoeckert Instrumente1999-12-20
STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS (K990512)Stoeckert Instrumente1999-11-23
AMMEX TUBING ORGANIZER (K934782)Ammex Cardiopulmonary Corp.1993-11-18
CARDIO2 CYCLE (K926233)Ergometrix, Inc.1993-06-04
TUBE GRIP (K922404)Georgia Medical Products, Inc.1992-11-23
NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS (K892856)Acacia Laboratories, Inc.1989-11-08
CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 (K884893)American Omni Medical, Inc.1989-01-30
CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 (K884640)American Omni Medical, Inc.1989-01-24
HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR (K874605)Mallinckrodt Critical Care1988-02-02
CPE 2000 CARDIO PULMONARY ERGOMETER (K874925)Medical Graphics Corp.1988-01-19
STOCKERT-SHILEY CAPS VENOUS OCCLUSION CLAMP (K864890)Shiley, Inc.1987-02-19
STOCKERT-SHILEY CAPS 4 CHANNEL TEMP. MONITOR 1 (K862510)Shiley, Inc.1986-07-17
ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE (K862549)American Bentley1986-07-15
STABLELINE (K860298)Cardio Metrics, Inc.1986-04-02
ADJUSTABLE OXYGENATOR HOLDER MODEL NO. BCM-HL (K860672)American Bentley1986-03-03
CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH (K854113)American Bentley1986-01-08
GAMBRO DIGITAL TELETHERMOMETER TTH 10-200 (K852455)Gambro, Inc.1985-09-16
CARDIAC COOLING JACKET (K851077)Pat O. Daily1985-07-11
COBE GAS FILTER (K851289)Cobe Laboratories, Inc.1985-06-19
HOLDER FOR BOS-10, 10S 5S (K841812)American Bentley1984-06-11
TUBE TENDER (K841296)The Anspach Effort, Inc.1984-06-11
HOLDER FOR MODELS AF-10,1025,1040,5 (K841032)American Bentley1984-04-17
SHILEY GAS FILTER (K832704)Shiley, Inc.1983-09-29
GASLINE FILTER #GF-10 (K832411)American Bentley1983-09-12
HOLDER FOR BOS-2S INFANT BUBBLE OXYGENA- (K830167)American Bentley1983-03-11
D645-BACTERIOLOGICAL GAS LINE FILTER (K822097)Electromedics, Inc.1982-07-30
TMO INTEGRATED CIRCUIT SYSTEM (K820406)Travenol Laboratories, S.A.1982-03-02
TEMPERATURE PROBES (K813271)Webster Laboratories, Inc.1981-12-29
CARDIOPLEGIA COOLING & ADMIN. SETS (K811368)Bentley Laboratories, Inc.1981-06-09
CARDIOPULMONARY BYPASS ACCESSORY EQUIP. (K811348)Bentley Laboratories, Inc.1981-05-29
SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS (K810079)3M Health Care, Sarns1981-01-30
DISPOSABLE CONNECTORS (K802542)Texas Medical Products, Inc.1981-01-16
DISPOSABLE GAS LINE FILTER (K802539)Texas Medical Products, Inc.1981-01-16
DISPOSABLE PARALLEL Y CONNECTORS (K802541)Texas Medical Products, Inc.1981-01-16
WILLIAM HARVEY OXYGENATING GAS FILTER (K802906)C.R. Bard, Inc.1980-12-16
OXYGENATOR GAS LINE FILTER (K792151)Cardio Systems, Inc.1979-11-13
SHILEY QUICK DISCONNECT ASSEMBLY (K791829)Shiley, Inc.1979-10-02
SARNO SINGLE POLE MAST (K790192)Sames, Inc.1979-02-08
FILTER, EXTRACORPOREAL BLOOD HOLDER (K781861)Surgikos, Inc.1978-11-15
PVC QUICK PRIME LINES (K780984)Norton Performance Plastics Corp.1978-07-17
VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR (K770681)Scimed Life Systems, Inc.1977-04-26

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