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510(k) K950315

CORDIS CSF RESERVOIR by Cordis Corp. — Product Code LKG

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

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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)
  • K874468 — P-S MEDICAL VENTRICULAR ACCESS PORT (February 11, 1988)
  • K874498 — CSF-VENTRICULOSTOMY RESERVOIR (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)