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FDA 510(k)

CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack)

K-Number: K181038 · 2018-10-10

ApplicantCormatrix Cardiovascular, Inc.
Decision Date2018-10-10
Product CodePSQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack) is a medical device manufactured by Cormatrix Cardiovascular, Inc.. It received FDA 510(k) clearance on 2018-10-10 under approval number K181038. The device is classified under product code PSQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack)?

CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack) is a medical device that received FDA 510(k) clearance on 2018-10-10. It is manufactured by Cormatrix Cardiovascular, Inc.. The 510(k) number is K181038.

When was CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack) approved by the FDA?

CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack) received FDA 510(k) clearance on 2018-10-10, under approval number K181038.

What company makes CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack)?

CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack) is manufactured by Cormatrix Cardiovascular, Inc..

What is the FDA product code for CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack)?

The FDA product code for CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack) is PSQ.

Related Clinical Trials

NCT04624646 Clinical Implication of Atrial Fibrillation Detection Using Wearable Device in Patients With Cryptogenic Stroke ACTIVE_NOT_RECRUITING NCT05906004 Post-Market Clinical Follow-up (PMCF) Study of the Pitch-Patch for the Augmentation or Reinforcement of the Rotator Cuff RECRUITING NCT05490459 Jewel Electrophysiology (EP) Lab Study COMPLETED

Other Devices by Cormatrix Cardiovascular, Inc.

K152127CorMatrix Tyke

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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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