Atlas FDA

REDIFURL AND TEPERSEAL DL INTRA-AORTIC BALLOON CATHETERS WITH HYDROMER COATING

FDA 510(k) clearance K935184 · decided 1995-02-10

Clearance details

K-number
K935184
Device name
REDIFURL AND TEPERSEAL DL INTRA-AORTIC BALLOON CATHETERS WITH HYDROMER COATING
Applicant
St. Jude Medical, Inc.
Decision
Substantially Equivalent
Date received
1993-10-26
Decision date
1995-02-10
Days to decision
472 days
Clearance type
Traditional
Product code
DSP
Device class
2
Regulation number
870.3535
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Chelmsford, MA, 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.

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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
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S094)St. Jude Medical, Inc.2016-02-12
SENSOLOG / DIALOG/ REGENCY FAMILY OF PACEMAKERS (P880006/S093)St. Jude Medical, Inc.2015-08-27
SESOLOG / DIALOG / REGENCY FAMILY OF PACEMAKERS (P880006/S092)St. Jude Medical, Inc.2015-02-25
SENSOLOG/ DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S089)St. Jude Medical, Inc.2014-09-12
SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S088)St. Jude Medical, Inc.2014-05-29
SENSOLOG/ DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S081)St. Jude Medical, Inc.2014-04-10
SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS (P880006/S085)St. Jude Medical, Inc.2014-03-20
SENSOLOG/DIALOG/ REGENCY FAMILY OF PACEMAKERS (P880006/S087)St. Jude Medical, Inc.2014-02-26