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510(k) K934545

PS MEDICAL DELTA BURR HOLE VALVE by Pudenz-Schulte Medical Research Corp. — Product Code JXG

K934545 is an FDA 510(k) premarket notification submitted by Pudenz-Schulte Medical Research Corp. for the device "PS MEDICAL DELTA BURR HOLE VALVE". The FDA issued a decision of Substantially Equivalent on April 28, 1994. The device falls under product code JXG (Shunt, Central Nervous System And Components), 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
April 28, 1994
Date Received
September 22, 1993
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)
  • K951258 — PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT (September 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)
  • 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)

Other clearances for product code JXG

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  • K251598 — Intellidrop (December 10, 2025)
  • K250636 — Sophy Mini Monopressure Valve (SM1) (November 28, 2025)
  • K252514 — EVAC-MRI (November 5, 2025)
  • K243531 — Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology (August 8, 2025)
  • K243552 — Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with (August 6, 2025)
  • K242974 — External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Cathet (June 20, 2025)
  • K243205 — EVAC (June 3, 2025)
  • K243676 — Duet External Drainage and Monitoring System (EDMS) (March 10, 2025)
  • K242003 — XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set (December 16, 2024)

FDA data resources