Atlas FDA

DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES

FDA 510(k) clearance K041281 · decided 2004-06-07

Clearance details

K-number
K041281
Device name
DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES
Applicant
Datascope Corp.
Decision
Substantially Equivalent
Date received
2004-05-13
Decision date
2004-06-07
Days to decision
25 days
Clearance type
Special
Product code
DSP
Device class
2
Regulation number
870.3535
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Fairfield, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01 recall (Z-0311-2025)Datascope Corp.2024-11-05
LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter p recall (Z-2223-2023)Datascope Corp.2023-07-21
LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic bal recall (Z-0131-2023)Datascope Corporation2022-10-24
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N: 0684-00-0478 recall (Z-2838-2020)Datascope Corporation2020-08-21
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479 recall (Z-2839-2020)Datascope Corporation2020-08-21
Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N: 0684-00-0480 recall (Z-2840-2020)Datascope Corporation2020-08-21
LINEAR 7.5 FR. 40cc IAB Catheter Maquet Getinge Group recall (Z-2568-2014)Datascope Corporation2014-09-03

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