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510(k) K910917

CATHLAB SILICONE BILIARY BALLOON CATHETER by Cathlab Corp. — Product Code GCA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1991
Date Received
March 5, 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 Cathlab Corp.

  • K910916 — CATHLAB SILICONE OCCLUSION BALLOON CATHETER (June 24, 1991)
  • K905139 — CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETER (February 25, 1991)
  • K897051 — MILLER PERCUTANEOUS ANGIOGRAPHIC/SCOPIC IRRI. CATH (March 16, 1990)
  • K897184 — 3F AND 4F IRRIGATION EMBOLECTOMY CATHETERS (March 14, 1990)
  • K893435 — SILICONE FLOW-DIRECTED THERMODILUTION CATHETER (September 26, 1989)
  • K893680 — SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH. (August 1, 1989)
  • K881455 — EMBOLECTOMY CATHETER(MODIFIED) (June 15, 1988)

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  • K210660 — Stone Retrieval Balloon Catheter (April 27, 2021)
  • K200173 — Stone Retrieval Balloon (May 1, 2020)
  • 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)