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510(k) K950315

CORDIS CSF RESERVOIR by Cordis Corp. — Product Code LKG

K950315 is an FDA 510(k) premarket notification submitted by Cordis Corp. for the device "CORDIS CSF RESERVOIR". The FDA issued a decision of Substantially Equivalent (kit) on May 9, 1995. The device falls under product code LKG (Port & Catheter, Implanted, Subcutaneous, Intraventricular), a Class II device regulated under 21 CFR 882.5550. Cordis Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
May 9, 1995
Date Received
January 26, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Port & Catheter, Implanted, Subcutaneous, Intraventricular
Device Class
Class II
Regulation Number
882.5550
Review Panel
HO
Submission Type

Other clearances by Cordis Corp.

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

Other clearances for product code LKG

  • K881690 — PORT-A-CATH PORTAL INTRODUCER FORCEPS (May 20, 1988)
  • K881493 — PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF. (May 20, 1988)
  • K874498 — CSF-VENTRICULOSTOMY RESERVOIR (February 11, 1988)
  • K874468 — P-S MEDICAL VENTRICULAR ACCESS PORT (February 11, 1988)
  • K833822 — P-S MEDICAL CSF ACCESS DEV 15MM/25MM (May 25, 1984)
  • K833672 — HH SUBCUTANEOUS ACCESS PORT (March 6, 1984)
  • K823790 — VENTRICULAR ACCESS SYSTEM (April 28, 1983)

FDA data resources