Atlas FDA

DWB

21 FDA 510(k) clearances · Product code

110 daysmedian time to decision
245 days90th percentile
21clearances measured

FDA profile

Official device name
Pump, Blood, Cardiopulmonary Bypass, Roller Type
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4370
Medical specialty
Cardiovascular
Flags
Life-sustaining
Adverse events (MAUDE)
2019: 155 · 2020: 79 · 2021: 58 · 2022: 87 · 2023: 49 · 2024: 39
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 (K162843)Terumo Cardiovascular Systems Corporation2016-11-17
LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST (K131618)Terumo Cardiovascular Systems Corporation2013-09-27
ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR, (K112587)Terumo Cardiovascular Systems Corp.2011-12-19
CSS-CARDIOPLEGIA SAFETY SYSTEM (K973237)Medtronic Bio-Medicus, Inc.1998-04-27
S3 MAST PUMP (K972321)Stoeckert Instrumente1998-02-27
S3 CYCLIC RPM CONTROL (K971520)Stoeckert Instrumente1997-09-10
COBE CENTURY PERFUSION PUMP (K960974)Cobe Cardiovascular, Inc.1997-07-14
SARNS 9000 UNIVERSAL ROLLER PUMP (K953904)3M Health Care, Ltd.1996-04-19
SARNS 800 ROLLER PUMP (K953901)3M Health Care, Sarns1996-04-19
STOCKERT S3 DOUBLE HEAD PUMP MODULE (K955038)Stoeckert Instrumente1996-02-21
MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP (K890904)Shiley, Inc.1989-04-12
VASCUCARE ANGIOPUMP (K881780)Vascucare, Inc.1988-09-28
ANGIOMED INTRODUCING SETS (K874771)Angiomed U.S., Inc.1988-01-12
STOCKERT-SHILEY MULTIFLOW ROLLER PUMP MODULE (K861714)Shiley, Inc.1986-07-16
STOCKERT-SHILEY DOUBLE HEAD PUMP MODULE (K862116)Shiley, Inc.1986-07-16
CARDIOPLEGIA RECIRCULATION SYS-BL 705/A (K831458)Electromedics, Inc.1983-10-20
SARNS PULSATILE PUMP (K820729)3M Health Care, Sarns1982-11-01
PUMP MODULES PMO LO-110-PMD 10-210 (K822071)Gambro, Inc.1982-08-24
POLYSTAN VERTICLUDE BLOOD PUMP (K813035)Advocacy International, Ltd.1981-11-27
COBE/STOCKERT BATTERY MODULE (K802714)Cobe Laboratories, Inc.1980-11-26
BLOOD PUMP MODEL 7000 (K780942)3M Health Care, Sarns1978-06-19

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