CARBOMEDICS VALVE TESTER— 510(k) K960169

Substantially Equivalent

Carbomedics, Inc.

FDA 510(k) clearance K960169 for CARBOMEDICS VALVE TESTER, Substantially Equivalent on 1996-04-15. Applicant: Carbomedics, Inc.. Device class: 1.

Clearance details

Applicant: Carbomedics, Inc.
Product code: Code DTJ
Device class: Class 1
Regulation: 21 CFR 870.3935
Advisory panel: Cardiovascular
Date received: 1996-01-16
Decision date: 1996-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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K880052 — EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR1988-04-01
K871596 — IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU)1987-06-15

More clearances from Carbomedics, Inc.

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K960923 — CARBOMEDICS MITRAL ROTATOR1996-04-29
K960706 — VASCUTEK VASCUSOFT PLUS VASCULAR GRAFT1996-04-25
K955588 — VASCUTEK GRAFT SIZER SET1996-03-07

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