Atlas FDA

CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX

FDA 510(k) clearance K031636 · decided 2003-08-11

Clearance details

K-number
K031636
Device name
CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX
Applicant
Datascope Corp.
Decision
Substantially Equivalent
Date received
2003-05-27
Decision date
2003-08-11
Days to decision
76 days
Clearance type
Abbreviated
Product code
DSP
Device class
2
Regulation number
870.3535
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mahwh, NJ, US
Third-party review
No
Expedited review
No

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

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Recalls involving this device

RecordFirmDate
CS100 IABP. Software Version CS100 IABP Q.01. recall (Z-1486-2026)Datascope Corp.2026-03-03
CS 100i Intra-Aortic Balloon Pump recall (Z-2736-2017)Maquet Datascope Corp - Cardiac Assist Division2017-06-23
CS 100 Intra-Aortic Balloon Pump recall (Z-2737-2017)Maquet Datascope Corp - Cardiac Assist Division2017-06-23
Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Ao recall (Z-1523-2014)Maquet Datascope Corp - Cardiac Assist Division2014-05-21
Datascope/ Maquet IABPs. System 98/98XT Intra-Aortic Balloon Pump; CS100/CS100i Intra-Aort recall (Z-2414-2011)Maquet Datascope Corp - Cardiac Assist Division2011-06-13
CS100 Intra-Aortic Balloon Pump. recall (Z-1811-2010)Datascope Corporation2010-06-21

PMA approvals by this applicant

RecordFirmDate
ABSORBABLE COLLAGEN HEMOSTAT (P850023/S014)Datascope Corp.1994-12-22
HEMOPAD(TM) ABSORBABLE COLLAGEN HEMOSTAT (P850023/S010)Datascope Corp.1992-11-16
ABSORBABLE COLLAGEN HEMOSTAT (P850023/S013)Datascope Corp.1992-08-26
HEMAFLEX (TM) MED-CHEM PRODUCTS,DISTRIBUTOR (P850023/S011)Datascope Corp.1991-10-04
NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S009)Datascope Corp.1990-09-28
NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S005)Datascope Corp.1989-05-17
NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S008)Datascope Corp.1989-03-09
NOVACOL(TM) TEXTURED COLLAGEN HEMOSTATIC AGENT (P850023/S006)Datascope Corp.1988-09-09