Cleared Traditional

PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV

K890182 · Aesculap Instruments Corp. · Cardiovascular
Feb 1990
Decision
406d
Days
Class 2
Risk

About This 510(k) Submission

K890182 is an FDA 510(k) clearance for the PROTEGRAFT DV 1500, 1900 & LOW POR, UNIGRAFT DV, a Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (Class II — Special Controls, product code DSY), submitted by Aesculap Instruments Corp. (Danville, US). The FDA issued a Cleared decision on February 28, 1990, 406 days after receiving the submission on January 18, 1989. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3450.

Submission Details

510(k) Number K890182 FDA.gov
FDA Decision Cleared SESE
Date Received January 18, 1989
Decision Date February 28, 1990
Days to Decision 406 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3450

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