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510(k) K803258

CORDIS HAKIM ASCITES VALVE SYSTEM by Cordis Corp. — Product Code KPM

K803258 is an FDA 510(k) premarket notification submitted by Cordis Corp. for the device "CORDIS HAKIM ASCITES VALVE SYSTEM". The FDA issued a decision of Substantially Equivalent on Jan 15, 1981. The device falls under product code KPM (Shunt, Peritoneal), a Class II device regulated under 21 CFR 876.5955. Cordis Corp. has 314 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 15, 1981
Date Received
Dec 23, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Peritoneal
Device Class
Class II
Regulation Number
876.5955
Review Panel
GU
Submission Type
510(k)

Other clearances by Cordis Corp.

  • K130981 — FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY… (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… (Feb 6, 2008)
  • K060877 — PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL… (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… (Dec 22, 2003)

Other clearances for product code KPM

  • K231096 — Automatic Continuous Effusion Shunt (ACES) System ACES System (Aug 18, 2023)
  • K170405 — BD Curve Ascites Shunt (Nov 2, 2017)
  • K012235 — DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL… (Oct 4, 2001)
  • K011862 — DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT (Jul 12, 2001)
  • K011020 — DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER (Jun 1, 2001)
  • K003451 — DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES… (Jan 2, 2001)
  • K973129 — DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS (Mar 17, 1998)
  • K962814 — DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER (Apr 14, 1997)
  • K913728 — DENVER(R) PERITONEO-SUBCLAVIAN SHUNT (Feb 18, 1994)
  • K901360 — LEVEEN PERITINEO-VENOUS SHUNT (Aug 21, 1990)

FDA data resources