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510(k) K882479

26MM DIAMETER HANCOCK* TROCAR BLADE AND TIP by Medtronic Blood Systems, Inc. — Product Code DWS

K882479 is an FDA 510(k) premarket notification submitted by Medtronic Blood Systems, Inc. for the device "26MM DIAMETER HANCOCK* TROCAR BLADE AND TIP". The FDA issued a decision of Substantially Equivalent on July 18, 1988. The device falls under product code DWS (Instruments, Surgical, Cardiovascular), a Class I device regulated under 21 CFR 870.4500. Medtronic Blood Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1988
Date Received
June 16, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instruments, Surgical, Cardiovascular
Device Class
Class I
Regulation Number
870.4500
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)
  • K885154 — INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM (February 22, 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)

Other clearances for product code DWS

  • K022238 — MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 (October 9, 2002)
  • K964445 — OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006) (January 30, 1997)
  • K962771 — BURKE CONGENITAL THORACOSCOPY INSTRUMENTS (November 19, 1996)
  • K955689 — RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY (May 15, 1996)
  • K960139 — G.E. STERILE ANGIOGRAPHIC TRAY (April 19, 1996)
  • K960144 — G.E. STERILE CT BIOPSY TRAY (April 15, 1996)
  • K960143 — G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY (April 9, 1996)
  • K934727 — REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER (January 10, 1994)
  • K900379 — HYCULT DIAMOND CORONARY BYPASS KNIFE (March 19, 1990)
  • K896307 — INSULATION PAD (January 19, 1990)

FDA data resources