FDA 510(k)

LARS AC Band Device

K-Number: K190143 · 2019-11-04

Decision Date2019-11-04

Product CodeHTN

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

LARS AC Band Device is a medical device manufactured by Corin USA. It received FDA 510(k) clearance on 2019-11-04 under approval 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. It is manufactured by Corin USA. The 510(k) number is K190143.

When was LARS AC Band Device approved by the FDA?

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

What company makes LARS AC Band Device?

LARS AC Band Device is manufactured by Corin USA.

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

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

Other Devices by Corin USA

K152893Corin Optimized Positioning System (OPS) K152903REVIVAL(TM) Modular Revision Hip Stem K183038Corin Optimized Positioning System (OPS) Plan K181061Corin Optimized Positioning System (OPS) Femoral K190834Corin Optimized Position System Functional Hip Analysis (OPS FHA) K202805Optimized Positioning System (OPS) Insight

View all 12 devices →

Related Devices (Code: HTN)

K153211M-Fix Acromioclavicular DeviceCoracoid Solutions, Inc. K173550Akros FibuLink Syndesmosis Repair KitAkros Medical K172620SyndesMetrics Syndesmosis Repair SystemMortise Medical, LLC K170249GRAVITY Syndesmosis LPWrightmedicaltechnologyinc K162996INVISIKNOT Ankle Syndesmosis Repair KitSmith & Nephew, Inc. K170440KISSloc Suture SystemArthrosurface, Inc.

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.