Cleared Traditional

MCAS (MODULAR CLIP APPLIER SYSTEM)

K983744 · Applied Medical Resources · Cardiovascular
Jan 1999
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K983744 is an FDA 510(k) clearance for the MCAS (MODULAR CLIP APPLIER SYSTEM), a Clip, Vascular (Class II — Special Controls, product code DSS), submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on January 21, 1999, 90 days after receiving the submission on October 23, 1998. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3250.

Submission Details

510(k) Number K983744 FDA.gov
FDA Decision Cleared SESE
Date Received October 23, 1998
Decision Date January 21, 1999
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSS — Clip, Vascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3250

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