Atlas FDA

IABP #90 SYSTEM

FDA 510(k) clearance K831235 · decided 1985-02-08

Clearance details

K-number
K831235
Device name
IABP #90 SYSTEM
Applicant
Datascope Corp.
Decision
Substantially Equivalent
Date received
1983-04-15
Decision date
1985-02-08
Days to decision
665 days
Clearance type
Traditional
Product code
DSP
Device class
2
Regulation number
870.3535
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Walker, 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
AC3™ Range™ Intra-Aortic Balloon Pump (K250542)Arrow International, LLC2025-03-26
AC3™ Series IABP (K232343)Arrow International, LLC2023-08-30
AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP (K201112)Arrow International, Inc.2020-05-27
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit (K200634)Arrow International, Inc.2020-04-09
AC3 Series Intra-Aortic Balloon Pump (IABP) (K192238)Arrow International, Teleflex2019-11-12
UltraFlex IAB (K190101)Arrow International, Inc.2019-06-28
Fiberoptix IAB (K190117)Arrow International, Inc.2019-06-13
CARDIOSAVE Intra-Aortic Balloon Pump (K181122)Datascope Corp.2018-05-31
CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump (K172305)Datascope Corp.2017-10-12
AC3 Series IABP System (K162820)Arrow International, Inc.2017-03-31
CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case (K163542)Datascope Corp.2017-01-31
CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (K151254)Datascope Corp.2015-07-02

Recalls involving this device

No recalls on record reference this clearance.

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