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FDA 510(k)

AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector

K-Number: K200674 · 2020-07-02

ApplicantAtrility Medical, LLC
Decision Date2020-07-02
Product CodeDSA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector is the device name listed in this FDA 510(k) record. The listed applicant is Atrility Medical, LLC. It received FDA 510(k) clearance on 2020-07-02 under 510(k) number K200674. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector?

AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector is a medical device that received FDA 510(k) clearance on 2020-07-02. The listed applicant is Atrility Medical, LLC. The 510(k) number is K200674.

When did AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector receive FDA 510(k) clearance?

AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector received FDA 510(k) clearance on 2020-07-02, under 510(k) number K200674.

Who is the listed applicant for AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector?

The FDA 510(k) record lists Atrility Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector?

The FDA product code for AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector is DSA.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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