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Medtronic Blood Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K944966UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492July 14, 1995
K944957TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500July 14, 1995
K893207CLOSED CHEST SUPPORT CIRCUITDecember 12, 1989
K893678DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601HNovember 27, 1989
K891687EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACEMay 31, 1989
K891230MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV.May 19, 1989
K885154INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEMFebruary 22, 1989
K884390INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTERDecember 21, 1988
K884244INTERSEPT* PREBYPASS FILTERDecember 5, 1988
K883439INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEMOctober 13, 1988
K883086INTERSEPT*PREBYPASS FILTERSeptember 16, 1988
K882137EXTENDED SHELF LIFE FOR INTERSEPT* ARTERIAL 20/40August 12, 1988
K882136INTERSEPT* OXYGEN GAS LINE FILTERAugust 11, 1988
K88247926MM DIAMETER HANCOCK* TROCAR BLADE AND TIPJuly 18, 1988
K880671MODIFIED INTERSEPT PEDIATRIC BLOOD FILTERMay 6, 1988