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510(k) K910372

INTIMAX THROMBECTOMY CATHETER by Applied Vascular Devices, Inc. — Product Code DXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 1991
Date Received
January 29, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Embolectomy
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type

Other clearances by Applied Vascular Devices, Inc.

  • K911730 — SURGICAL OBTURATOR WITH SEAL (December 23, 1991)
  • K911589 — DISPOSABLE SURGICAL TROCAR WITH SEAL (July 5, 1991)
  • K910339 — AVD INTIMAX OCCLUSION CATHETER (May 29, 1991)
  • K911181 — INTIMAX(TM) IRRIGATION CATHETER (April 18, 1991)
  • K910493 — AVD INTIMAX CHOLANGIOGRAPHY CATHETER (March 28, 1991)
  • K903848 — DIAGNOSTIC INTRASCULAR CATHETER (March 25, 1991)
  • K905738 — OPERATIVE CHOLANGIOGRAPHIC CATHETER (March 21, 1991)
  • K910079 — DISPOSABLE INTRODUCER SHEATH (February 27, 1991)
  • K902256 — IRRIGATION CATHETER 4, 6 AND 10 FRENCH (February 15, 1991)
  • K904379 — SURGICAL TROCAR AND CANNULA (December 21, 1990)

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  • K233819 — Fogarty Venous Thrombectomy Catheters (May 22, 2024)
  • K233619 — Fogarty Corkscrew Catheters; Fogarty Graft Thrombectomy Catheters (May 20, 2024)
  • K213771 — Merlin Aspiration System (January 27, 2022)
  • K202049 — Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter (September 7, 2021)
  • K193379 — Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe (June 12, 2020)
  • K163031 — Bunegin-Albin Air Aspiration Set (July 27, 2017)
  • K163353 — Needle's Eye Snare Retrieval Set - 54cm (July 11, 2017)