Atlas FDA

SARNS 9000 UNIVERSAL ROLLER PUMP

FDA 510(k) clearance K953904 · decided 1996-04-19

Clearance details

K-number
K953904
Device name
SARNS 9000 UNIVERSAL ROLLER PUMP
Applicant
3M Health Care, Ltd.
Decision
Substantially Equivalent
Date received
1995-08-18
Decision date
1996-04-19
Days to decision
245 days
Clearance type
Traditional
Product code
DWB
Device class
2
Regulation number
870.4370
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Ann Arbor, MI, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

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 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

Recalls involving this device

RecordFirmDate
Terumo Perfusion System 8000 Roller Pump, 115V; Model 8000; Catalog No. 16402. recall (Z-1002-2007)Terumo Cardiovascular Systems Corp2007-07-07
Terumo Perfusion System 8000 Roller Pump, 220/240V; Model 8000; Catalog No. 16407. recall (Z-1003-2007)Terumo Cardiovascular Systems Corp2007-07-07
Terumo Perfusion System 9000 Roller Pump; Model 9000; Catalog No. 16395. recall (Z-1004-2007)Terumo Cardiovascular Systems Corp2007-07-07