Cleared Traditional Expedited

TEMPORARY LIMB SALVAGE SHUNT

K070323 · Vascutek, Ltd. · Cardiovascular
Feb 2007
Decision
13d
Days
Class 2
Risk

About This 510(k) Submission

K070323 is an FDA 510(k) clearance for the TEMPORARY LIMB SALVAGE SHUNT, a Clamp, Vascular (Class II — Special Controls, product code DXC), submitted by Vascutek, Ltd. (Renfrewshire, Glasgow, GB). The FDA issued a Cleared decision on February 15, 2007, 13 days after receiving the submission on February 2, 2007. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number K070323 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 2007
Decision Date February 15, 2007
Days to Decision 13 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXC — Clamp, Vascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4450

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