P-S MEDICAL VENTRICULAR ACCESS PORT— 510(k) K874468

Name: FDA 510(k) clearance K874468
Creator: U.S. Food and Drug Administration
Published: 1988-02-11

Substantially Equivalent

Pudenz-Schulte Medical Research Corp.

FDA 510(k) clearance K874468 for P-S MEDICAL VENTRICULAR ACCESS PORT, Substantially Equivalent on 1988-02-11. Applicant: Pudenz-Schulte Medical Research Corp.. Device class: 2.

Clearance details

Applicant: Pudenz-Schulte Medical Research Corp.
Product code: Code LKG
Device class: Class 2
Regulation: 21 CFR 882.5550
Advisory panel: Neurology
Date received: 1987-11-02
Decision date: 1988-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Goleta, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LKG

view all

K950315 — CORDIS CSF RESERVOIR1995-05-09
K881493 — PORT-A-CATH IMPLANTABLE ACCESS SYSTEM - KIT CONF.1988-05-20
K881690 — PORT-A-CATH PORTAL INTRODUCER FORCEPS1988-05-20
K874498 — CSF-VENTRICULOSTOMY RESERVOIR1988-02-11
K833822 — P-S MEDICAL CSF ACCESS DEV 15MM/25MM1984-05-25

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.