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510(k) K911181

INTIMAX(TM) IRRIGATION CATHETER by Applied Vascular Devices, Inc. — Product Code GCA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1991
Date Received
March 18, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
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)
  • K910372 — INTIMAX THROMBECTOMY CATHETER (April 26, 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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  • K210660 — Stone Retrieval Balloon Catheter (April 27, 2021)
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  • K200247 — Fusion Quattro Extraction Balloon (February 27, 2020)
  • K193344 — Tri-Ex Extraction Balloon with Multiple Sizing (December 13, 2019)
  • K173659 — Howell D.A.S.H Extraction Balloon with Multiple Sizing (July 6, 2018)
  • K173414 — Advance Biliary Balloon Catheter (June 22, 2018)
  • K170292 — Tri-Ex Extraction Balloon With Multiple Sizing (September 20, 2017)
  • K063677 — FUSION QUATTRO EXTRACTION BALLOON XL (January 5, 2007)