PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER— 510(k) K930606

Name: FDA 510(k) clearance K930606
Creator: U.S. Food and Drug Administration
Published: 1993-09-10

Substantially Equivalent

Pudenz-Schulte Medical Research Corp.

FDA 510(k) clearance K930606 for PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER, Substantially Equivalent on 1993-09-10. Applicant: Pudenz-Schulte Medical Research Corp.. Device class: 1.

Clearance details

Applicant: Pudenz-Schulte Medical Research Corp.
Product code: Code GYK
Device class: Class 1
Regulation: 21 CFR 882.4545
Advisory panel: Neurology
Date received: 1993-02-05
Decision date: 1993-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goleta, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GYK

view all

K962761 — REIGEL TUNNELING DEVICE1996-10-11
K934391 — V/P AND L/P CATHETER PASSERS1993-11-19
K932273 — CORDIS TUNNELER1993-08-23
K895868 — HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE1989-10-31
K883607 — PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER1988-09-30

More clearances from Pudenz-Schulte Medical Research Corp.

view all

K960055 — MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 89321996-09-30
K954409 — PS MEDICAL IPI VASCULAR ACCESS CATHETER1995-12-18
K951258 — PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT1995-09-18
K934167 — IPI DUAL LUMEN PORT1994-07-14
K934796 — IPI LOW PROFILE IMPORT1994-07-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.