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510(k) K072301

5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05 by Ev3, Inc. — Product Code FGE

Clearance Details

Decision
SESU ()
Decision Date
March 18, 2008
Date Received
August 17, 2007
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 Ev3, Inc.

  • K141118 — NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER (July 18, 2014)
  • K132777 — NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER (September 26, 2013)
  • K130911 — RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER (May 24, 2013)
  • K123544 — RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER (February 12, 2013)
  • K111723 — TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM (October 27, 2011)
  • K111010 — SPIDERFX EMBOLIC PROTECTION DEVICE (October 27, 2011)
  • K111490 — MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE (September 16, 2011)
  • K110319 — EVERCROSS 0.035 OTW PTA DILATATION CATHETER (April 14, 2011)
  • K103618 — TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM (January 5, 2011)
  • K103322 — EVERCROSS 0.035 OTW PTA DILATION CATHETER (December 6, 2010)

Other clearances for product code FGE

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  • K251123 — Niti-S Biliary Stent; Niti-S Biliary Slim M Stent (December 29, 2025)
  • K251019 — BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G (December 22, 2025)
  • 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)
  • K241888 — Single-use Balloon Dilatation Catheter (December 20, 2024)