MITRAL VALVE ORIFICE SIZER— 510(k) K820887

Substantially Equivalent

Celtech

FDA 510(k) clearance K820887 for MITRAL VALVE ORIFICE SIZER, Substantially Equivalent on 1982-07-08. Applicant: Celtech. Device class: 1.

Clearance details

Applicant: Celtech
Product code: Code DTI
Device class: Class 1
Regulation: 21 CFR 870.3945
Advisory panel: Cardiovascular
Date received: 1982-03-30
Decision date: 1982-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DTI

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K934951 — VALVE SIZER1993-12-10
K881279 — EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET1988-05-18
K853313 — DUROMEDICS CARDIAC VALVE SIZER SET1985-11-01
K852612 — METRONIC MODEL F7700 HEART VALVE SIZERS1985-09-23

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