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510(k) K003719

VASCULAR ARCHITECTS PERISCOPE DEVICE by Vascular Architects, Inc. — Product Code DWX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2001
Date Received
December 4, 2000
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

Other clearances by Vascular Architects, Inc.

  • K031641 — VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEM (August 1, 2003)
  • K030567 — MODIFICATION TO VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTRILLED EXPANSIO (March 24, 2003)
  • K012544 — VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTE (November 15, 2001)
  • K003173 — ASPIRE COVERED STENT AND DELIVERY CATHETER (March 13, 2001)

Other clearances for product code DWX

  • K121415 — MOLLRING MULTITASC (September 5, 2012)
  • K032105 — ENDOHELIX ENDARTERECTOMY DEVICE (October 30, 2003)
  • K020925 — CARBODISSECTING ENDOSCOPE (April 29, 2003)
  • 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)
  • K895878 — OLYMPUS VALVULOTOME W/DETACHABLE TIP (January 2, 1990)
  • K894496 — OLYMPUS VALVULOTOME W/FIXED TIP (October 12, 1989)