Home / 510(k) Clearances / K011018

510(k) K011018

TAUT BALLOON CATHETER, MODEL 50640 by Taut, Inc. — Product Code GCA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2001
Date Received
April 4, 2001
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 Taut, Inc.

  • K023261 — ADAPT BALLOON OPEN ACCESS PORT, MODEL 41244 (December 13, 2002)
  • K021731 — ADAPT OPEN ACCESS PORT, MODEL 41233 (August 8, 2002)
  • K010007 — ADAPT LAPAROSCOPIC PORT & ADAPT REDUCER CAP (February 22, 2001)
  • K003703 — TAUT-INSUFFLATION NEEDLE (February 22, 2001)
  • K992904 — MINI-PORT (October 5, 1999)
  • K992907 — INTRADUCER (October 5, 1999)
  • K972112 — INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450 (December 1, 1997)
  • K962003 — TUAT SPLATTER CONTROL SHIELD SCS-300 (July 18, 1996)
  • K960883 — INTRADUCER PERITONEAL CATHETER 6FRX3, 9FRX3 1/2, 10FRX4, 12FRX8 (March 20, 1996)
  • K945486 — SPLATTER CONTROL SHIELD (February 28, 1995)

Other clearances for product code GCA

  • K232752 — Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23 (February 26, 2024)
  • K212582 — SpyGlass Discover Balloon Dilation Catheter (May 6, 2022)
  • 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)