Atlas FDA

MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER

FDA 510(k) clearance K120868 · decided 2012-04-20

Clearance details

K-number
K120868
Device name
MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER
Applicant
Datascope Corp., Cardiac Assist Division
Decision
Substantially Equivalent
Date received
2012-03-22
Decision date
2012-04-20
Days to decision
29 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.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pu recall (Z-2219-2023)Datascope Corp.2023-07-21
Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0684-00-0294-01,0 recall (Z-2831-2020)Datascope Corporation2020-08-21
Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295- recall (Z-2832-2020)Datascope Corporation2020-08-21
Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, recall (Z-2833-2020)Datascope Corporation2020-08-21
Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-aortic balloon cath recall (Z-1383-2018)Datascope Corporation2018-04-16
Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon cath recall (Z-1384-2018)Datascope Corporation2018-04-16