Cleared Abbreviated

K983861: DISTAFLO BYPASS GRAFT

K983861 · Impra, Inc. · Cardiovascular

Nov 1998

Decision

22d

Days

Class 2

Risk

K983861 is an FDA 510(k) clearance for the DISTAFLO BYPASS GRAFT, a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (Class II — Special Controls, product code DSY), submitted by Impra, Inc. (Tempe, US). The FDA issued a Cleared decision on November 24, 1998, 22 days after receiving the submission on November 2, 1998. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number	K983861 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 02, 1998
Decision Date	November 24, 1998
Days to Decision	22 days
Submission Type	Abbreviated
Review Panel	Cardiovascular (CV)
Summary	Summary PDF