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510(k) K111627

SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM by Idev Technologies, Inc. — Product Code FGE

Clearance Details

Decision
SESU ()
Decision Date
August 21, 2012
Date Received
June 10, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stents, Drains And Dilators For The Biliary Ducts
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type

Other clearances by Idev Technologies, Inc.

  • K130591 — SUPERA VERITAS (May 2, 2013)
  • K122546 — SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYST (December 7, 2012)
  • K111766 — SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTE (October 19, 2011)
  • K093893 — SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYST (October 5, 2010)
  • K071646 — SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL (January 31, 2008)
  • K060557 — SURESAVE TM SELF-EXPANDABLE NITINOL STENT AND PRECISION TM DELIVERY CATHETER-SS0 (August 15, 2006)
  • K050926 — TEXAN LONGHORN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30120060 (May 9, 2005)
  • K041374 — AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060 (March 2, 2005)
  • K033188 — TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050 (November 19, 2003)
  • K030504 — AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060 (September 16, 2003)

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  • K250409 — Disposable Balloon Catheter (B5-2Q); Disposable Balloon Catheter (B7-2Q); Disp (October 21, 2025)
  • K251229 — EndoFix™Tissue Fixation System (August 20, 2025)
  • K243412 — ARCHIMEDES Biodegradable Pancreatic Stent (July 16, 2025)
  • K251291 — Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery (July 3, 2025)
  • K242845 — EGIS Biliary Double Bare Stent (BDB080405) (June 25, 2025)
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