Atlas FDA

SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE)

FDA 510(k) clearance K014161 · decided 2002-01-15

Clearance details

K-number
K014161
Device name
SJM TAILOR ANNULOPLASTY RING MODEL TARP- (SIZE)
Applicant
St. Jude Medical, Inc.
Decision
Substantially Equivalent
Date received
2001-12-19
Decision date
2002-01-15
Days to decision
27 days
Clearance type
Special
Product code
KRH
Device class
2
Regulation number
870.3800
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
St. Paul, MN, US
Third-party review
No
Expedited review
No

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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