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510(k) K003719

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

K003719 is an FDA 510(k) premarket notification submitted by Vascular Architects, Inc. for the device "VASCULAR ARCHITECTS PERISCOPE DEVICE". The FDA issued a decision of Substantially Equivalent on February 28, 2001. The device falls under product code DWX (Stripper, Artery, Intraluminal), a Class II device regulated under 21 CFR 870.4875. Vascular Architects, Inc. has at least 4 other 510(k) clearances on record.

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)

FDA data resources