Home / 510(k) Clearances / K885154

510(k) K885154

INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM by Medtronic Blood Systems, Inc. — Product Code KRJ

K885154 is an FDA 510(k) premarket notification submitted by Medtronic Blood Systems, Inc. for the device "INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM". The FDA issued a decision of Substantially Equivalent on February 22, 1989. The device falls under product code KRJ (Filter, Prebypass, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4280. Medtronic Blood Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1989
Date Received
December 15, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Prebypass, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4280
Review Panel
CV
Submission Type

Other clearances by Medtronic Blood Systems, Inc.

  • K944966 — UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492 (July 14, 1995)
  • K944957 — TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500 (July 14, 1995)
  • K893207 — CLOSED CHEST SUPPORT CIRCUIT (December 12, 1989)
  • K893678 — DURAN FLEXIBLE ANNULOPLASTY RING & OBTURATOR H601H (November 27, 1989)
  • K891687 — EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE (May 31, 1989)
  • K891230 — MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV. (May 19, 1989)
  • K884390 — INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER (December 21, 1988)
  • K884244 — INTERSEPT* PREBYPASS FILTER (December 5, 1988)
  • K883439 — INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEM (October 13, 1988)
  • K883086 — INTERSEPT*PREBYPASS FILTER (September 16, 1988)

Other clearances for product code KRJ

  • K990276 — POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER (October 1, 1999)
  • K982385 — POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER (February 1, 1999)
  • K940126 — AVECOR PRE-BYPASS FILTER (June 28, 1994)
  • K900672 — PREBYPASS FILTER, CAT. NO. FPB-5 (April 3, 1990)
  • K884390 — INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER (December 21, 1988)
  • K884244 — INTERSEPT* PREBYPASS FILTER (December 5, 1988)
  • K883086 — INTERSEPT*PREBYPASS FILTER (September 16, 1988)
  • K875094 — ULTIPOR PRE-BYPASS PLUS FILTER W/POSIDYNE MEMBRANE (February 29, 1988)
  • K871350 — PREBYPASS FILTER (June 8, 1987)
  • K861226 — INTERFACE CRYSTALLOID CARDIOPLEGIC FILTER MODEL 70 (June 2, 1986)

FDA data resources