Cleared Traditional

K983744 - MCAS (MODULAR CLIP APPLIER SYSTEM)

K983744 is an FDA 510(k) clearance for MCAS (MODULAR CLIP APPLIER SYSTEM), manufactured by Applied Medical Resources. The device is a Class 2 Cardiovascular device with product code DSS cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

K983744 is an FDA 510(k) clearance for the MCAS (MODULAR CLIP APPLIER SYSTEM). Classified as Clip, Vascular (product code DSS), Class II - Special Controls.

Submitted by Applied Medical Resources (Launa Hills, US). The FDA issued a Cleared decision on January 21, 1999 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3250 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Applied Medical Resources devices

FDA 510(k) Submission Details - K983744

510(k) Number K983744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSS Device Classification - Class 2, Special Controls

Product Code DSS Clip, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.