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FDA 510(k)

LARS AC Band Device

K-Number: K190143 · 2019-11-04

ApplicantCorin USA
Decision Date2019-11-04
Product CodeHTN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LARS AC Band Device is the device name listed in this FDA 510(k) record. The listed applicant is Corin USA. It received FDA 510(k) clearance on 2019-11-04 under 510(k) number K190143. The device is classified under product code HTN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LARS AC Band Device?

LARS AC Band Device is a medical device that received FDA 510(k) clearance on 2019-11-04. The listed applicant is Corin USA. The 510(k) number is K190143.

When did LARS AC Band Device receive FDA 510(k) clearance?

LARS AC Band Device received FDA 510(k) clearance on 2019-11-04, under 510(k) number K190143.

Who is the listed applicant for LARS AC Band Device?

The FDA 510(k) record lists Corin USA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LARS AC Band Device?

The FDA product code for LARS AC Band Device is HTN.

Other records listing Corin USA as applicant

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Related Devices (Code: HTN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253115LARS ACJMovmedix S.A.S.K252081SportLinc Syndesmosis DeviceLincotek MedicalK253727Syndesmosis TightRope PROArthrex, Inc.K251643Synchfix EVTWright Medical Technology, Inc. (Stryker Corporation)K251134RipCordTriMed, Inc.K243624Acu-Sinch Knotless MiniAcumed, LLC

Official Source

View on FDA Database →

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

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