DUROMEDICS CARDIAC VALVE SIZER SET— 510(k) K853313

Name: FDA 510(k) clearance K853313
Creator: U.S. Food and Drug Administration
Published: 1985-11-01

Substantially Equivalent

Hemex Scientific, Inc.

FDA 510(k) clearance K853313 for DUROMEDICS CARDIAC VALVE SIZER SET, Substantially Equivalent on 1985-11-01. Applicant: Hemex Scientific, Inc.. Device class: 1.

Clearance details

Applicant: Hemex Scientific, Inc.
Product code: Code DTI
Device class: Class 1
Regulation: 21 CFR 870.3945
Advisory panel: Cardiovascular
Date received: 1985-08-07
Decision date: 1985-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DTI

view all

K952184 — CARBOMEDICS SUPRA-ANNULAR VALVE SIZER1995-11-29
K934951 — VALVE SIZER1993-12-10
K881279 — EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET1988-05-18
K852612 — METRONIC MODEL F7700 HEART VALVE SIZERS1985-09-23
K820887 — MITRAL VALVE ORIFICE SIZER1982-07-08

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