Cleared Traditional

SAM JUNCTIONAL TOURNIQUET

K123694 · Sam Medical Products · Cardiovascular
Mar 2013
Decision
94d
Days
Class 2
Risk

About This 510(k) Submission

K123694 is an FDA 510(k) clearance for the SAM JUNCTIONAL TOURNIQUET, a Clamp, Vascular (Class II — Special Controls, product code DXC), submitted by Sam Medical Products (Wilsonville, US). The FDA issued a Cleared decision on March 7, 2013, 94 days after receiving the submission on December 3, 2012. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number K123694 FDA.gov
FDA Decision Cleared SESE
Date Received December 03, 2012
Decision Date March 07, 2013
Days to Decision 94 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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