VENTRICULAR ACCESS SYSTEM— 510(k) K823790

Name: FDA 510(k) clearance K823790
Creator: U.S. Food and Drug Administration
Published: 1983-04-28

Substantially Equivalent

American Heyer Schulte

FDA 510(k) clearance K823790 for VENTRICULAR ACCESS SYSTEM, Substantially Equivalent on 1983-04-28. Applicant: American Heyer Schulte. Device class: 2.

Clearance details

Applicant: American Heyer Schulte
Product code: Code LKG
Device class: Class 2
Regulation: 21 CFR 882.5550
Advisory panel: Neurology
Date received: 1982-12-16
Decision date: 1983-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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
K874468 — P-S MEDICAL VENTRICULAR ACCESS PORT1988-02-11
K874498 — CSF-VENTRICULOSTOMY RESERVOIR1988-02-11

More clearances from American Heyer Schulte

view all

K840172 — VENTRAL WALL DEFECT REDUCT SILO1984-06-27
K834593 — ONE-PIECE SHUNT1984-04-03
K833502 — RADOVAN SUBCUTANEOUS TISSUE EXPANDER1984-02-03
K833698 — AMER. V. MUELLER SURG. STAPLES ILA1984-01-25
K833704 — AMER. V. MUELLER SURGICALSTAPLES-CARTR1983-12-29

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