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510(k) K951258

PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT by Pudenz-Schulte Medical Research Corp. — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1995
Date Received
March 21, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Central Nervous System And Components
Device Class
Class II
Regulation Number
882.5550
Review Panel
NE
Submission Type

Other clearances by Pudenz-Schulte Medical Research Corp.

  • K960055 — MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 893 (September 30, 1996)
  • K954409 — PS MEDICAL IPI VASCULAR ACCESS CATHETER (December 18, 1995)
  • K934796 — IPI LOW PROFILE IMPORT (July 14, 1994)
  • K934167 — IPI DUAL LUMEN PORT (July 14, 1994)
  • K940096 — PS MEDICAL CATHETER PLACEMENT KIT (May 3, 1994)
  • K934545 — PS MEDICAL DELTA BURR HOLE VALVE (April 28, 1994)
  • K930206 — PS MEDICAL IPI ACCESS KIT (February 25, 1994)
  • K930606 — PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER (September 10, 1993)
  • K913412 — PS MEDICAL CSF-ACCESS DEVICE (March 30, 1993)
  • K922419 — IPI IMPORT (November 20, 1992)

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