DISTAFLO BYPASS GRAFT— 510(k) K983769

Substantially Equivalent

Impra, Inc.

FDA 510(k) clearance K983769 for DISTAFLO BYPASS GRAFT, Substantially Equivalent on 1998-12-15. Applicant: Impra, Inc.. Device class: 2.

Clearance details

Applicant: Impra, Inc.
Product code: Code DYF
Device class: Class 2
Regulation: 21 CFR 870.3450
Advisory panel: Cardiovascular
Date received: 1998-10-26
Decision date: 1998-12-15
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Tempe, AZ, US

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More clearances from Impra, Inc.

K004011 — IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS2001-03-27
K991027 — BI-DIRECTIONAL TUNNELER1999-04-22
K983861 — DISTAFLO BYPASS GRAFT1998-11-24
K983064 — IMPRA HIGH POROSITY GRAFT1998-11-19
K981076 — VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT1998-05-07

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