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510(k) K895878

OLYMPUS VALVULOTOME W/DETACHABLE TIP by Olympus Corp. — Product Code DWX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 1990
Date Received
October 5, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stripper, Artery, Intraluminal
Device Class
Class II
Regulation Number
870.4875
Review Panel
CV
Submission Type

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  • K931994 — RESECTOSCOPE SHEATH (February 17, 1994)
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  • K003719 — VASCULAR ARCHITECTS PERISCOPE DEVICE (February 28, 2001)
  • K950813 — MOLLRING CUTTER (July 25, 1995)
  • K933498 — EXTERNAL VEIN STRIPPER (March 23, 1994)
  • K913803 — INTRALUMINAL ARTERY STRIPPER (April 24, 1992)
  • K911099 — MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE (June 25, 1991)
  • K904944 — TRANSLUMINAL ENDARTERECTOMY DEVICE (December 17, 1990)
  • K894496 — OLYMPUS VALVULOTOME W/FIXED TIP (October 12, 1989)