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510(k) K032105

ENDOHELIX ENDARTERECTOMY DEVICE by Endarx, Inc. — Product Code DWX

K032105 is an FDA 510(k) premarket notification submitted by Endarx, Inc. for the device "ENDOHELIX ENDARTERECTOMY DEVICE". The FDA issued a decision of Substantially Equivalent on October 30, 2003. The device falls under product code DWX (Stripper, Artery, Intraluminal), a Class II device regulated under 21 CFR 870.4875.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2003
Date Received
July 8, 2003
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 for product code DWX

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

FDA data resources