Home / 510(k) Clearances / K023116

510(k) K023116

CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B by Cordis Corp. — Product Code DTK

K023116 is an FDA 510(k) premarket notification submitted by Cordis Corp. for the device "CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B". The FDA issued a decision of SESU on Oct 18, 2002. The device falls under product code DTK (Filter, Intravascular, Cardiovascular), a Class II device regulated under 21 CFR 870.3375. Cordis Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESU ()
Decision Date
Oct 18, 2002
Date Received
Sep 19, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Intravascular, Cardiovascular
Device Class
Class II
Regulation Number
870.3375
Review Panel
CV
Submission Type

Other clearances by Cordis Corp.

  • K130981 — FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EX (Mar 12, 2014)
  • K112797 — POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER (May 4, 2012)
  • K101651 — ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE (Jul 9, 2010)
  • K082143 — MICRO GUIDE CATHETER XP (Aug 25, 2008)
  • K062798 — SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB (Feb 6, 2008)
  • K060877 — PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,B (Apr 27, 2006)
  • K050645 — CORDIS AMIIA .014 PTA BALLOON CATHETER (Apr 1, 2005)
  • K040592 — CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE (Dec 17, 2004)
  • K042969 — MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (Nov 8, 2004)
  • K033394 — CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTE (Dec 22, 2003)

Other clearances for product code DTK

  • K242612 — Option ELITE Vena Cava Filter System (352506070E 352506100E) (Sep 10, 2024)
  • K240578 — VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter (Jul 31, 2024)
  • K241507 — ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK (Jun 26, 2024)
  • K240257 — Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit (Feb 29, 2024)
  • K233680 — Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM- (Jan 18, 2024)
  • K211874 — Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena (Jul 28, 2021)
  • K211875 — Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect (Jul 28, 2021)
  • K181202 — Sentry IVC Filter (Jun 6, 2018)
  • K173236 — Sentry IVC Filter (Feb 22, 2018)
  • K172584 — Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena (Nov 20, 2017)

FDA data resources