Cleared Abbreviated

K200674 - AtriAmp

K200674 is the FDA 510(k) clearance for AtriAmp by Atrility Medical, LLC. It is a Class 2 Cardiovascular device (product code DSA) cleared through the Abbreviated 510(k) pathway after a 108-day FDA review.

K200674 · Atrility Medical, LLC · Cardiovascular device
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Jul 2020
Decision
108d
Days
Class 2
Risk

K200674 is an FDA 510(k) clearance for the AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable O.... Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Atrility Medical, LLC (Madison, US). The FDA issued a Cleared decision on July 2, 2020 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2900 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Atrility Medical, LLC devices

Submission Details

510(k) Number K200674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2020
Decision Date July 02, 2020
Days to Decision 108 days
Submission Type Abbreviated
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
17d faster than avg
Panel avg: 125d · This submission: 108d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code DSA Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2900
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.

Regulatory Consultant

Quality & Regulatory Associates, LLC
Gary Syring

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DSA Cable, Transducer And Electrode, Patient, (including Connector)

All 47
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