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510(k) K942457

GRAFT THROMBECTOMY INSTRUMENTS by Intramed Laboratories, Inc. — Product Code MCW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1995
Date Received
May 24, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Peripheral, Atherectomy
Device Class
Class II
Regulation Number
870.4875
Review Panel
CV
Submission Type

Other clearances by Intramed Laboratories, Inc.

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  • K931792 — ARTHROSCOPE (June 13, 1994)
  • K925283 — VALVULOTOME (February 10, 1994)
  • K934696 — ANGIOSCOPE (January 18, 1994)
  • K922114 — ENDOSCOPIC RETRIEVAL BASKET (August 3, 1992)
  • K914385 — OPTICAL VALVULOTOME (March 2, 1992)
  • K904465 — FLEXIBLE ARTHROSCOPE (December 20, 1990)
  • K903528 — LAPAROSCOPE (September 4, 1990)
  • K902444 — CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP (August 30, 1990)
  • K901010 — FLEXIBLE CHOLEDOCHOSCOPE (May 22, 1990)

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