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510(k) K930606

PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER by Pudenz-Schulte Medical Research Corp. — Product Code GYK

K930606 is an FDA 510(k) premarket notification submitted by Pudenz-Schulte Medical Research Corp. for the device "PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER". The FDA issued a decision of Substantially Equivalent on September 10, 1993. The device falls under product code GYK (Instrument, Shunt System Implantation), a Class I device regulated under 21 CFR 882.4545. Pudenz-Schulte Medical Research Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 10, 1993
Date Received
February 5, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Shunt System Implantation
Device Class
Class I
Regulation Number
882.4545
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)
  • 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)
  • K913412 — PS MEDICAL CSF-ACCESS DEVICE (March 30, 1993)
  • K922419 — IPI IMPORT (November 20, 1992)

Other clearances for product code GYK

  • K962761 — REIGEL TUNNELING DEVICE (October 11, 1996)
  • K934391 — V/P AND L/P CATHETER PASSERS (November 19, 1993)
  • K932273 — CORDIS TUNNELER (August 23, 1993)
  • K895868 — HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE (October 31, 1989)
  • K883607 — PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER (September 30, 1988)
  • K873771 — HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO (December 18, 1987)
  • K865075 — H-H SUBGALEAL TROCAR (January 13, 1987)
  • K853370 — H-H CATHETER PASSERS(TACL DESIGN (September 18, 1985)
  • K853368 — H-H SHUNT INTRODUCER (September 6, 1985)
  • K841553 — H-H SHUNT PASSERS (May 14, 1984)

FDA data resources