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510(k) K874498

CSF-VENTRICULOSTOMY RESERVOIR by Pudenz-Schulte Medical Research Corp. — Product Code LKG

K874498 is an FDA 510(k) premarket notification submitted by Pudenz-Schulte Medical Research Corp. for the device "CSF-VENTRICULOSTOMY RESERVOIR". The FDA issued a decision of Substantially Equivalent on February 11, 1988. The device falls under product code LKG (Port & Catheter, Implanted, Subcutaneous, Intraventricular), a Class II device regulated under 21 CFR 882.5550. Pudenz-Schulte Medical Research Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 1988
Date Received
November 2, 1987
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 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)
  • K951258 — PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT (September 18, 1995)
  • K934167 — IPI DUAL LUMEN PORT (July 14, 1994)
  • K934796 — IPI LOW PROFILE IMPORT (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)

Other clearances for product code LKG

  • K950315 — CORDIS CSF RESERVOIR (May 9, 1995)
  • 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)
  • 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