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FDA 510(k)

C-QUR RPM MESH

K-Number: K121070 · 2012-04-26

ApplicantAtrium Medical Corp.
Decision Date2012-04-26
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

C-QUR RPM MESH is the device name listed in this FDA 510(k) record. The listed applicant is Atrium Medical Corp.. It received FDA 510(k) clearance on 2012-04-26 under 510(k) number K121070. The device is classified under product code FTL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C-QUR RPM MESH?

C-QUR RPM MESH is a medical device that received FDA 510(k) clearance on 2012-04-26. The listed applicant is Atrium Medical Corp.. The 510(k) number is K121070.

When did C-QUR RPM MESH receive FDA 510(k) clearance?

C-QUR RPM MESH received FDA 510(k) clearance on 2012-04-26, under 510(k) number K121070.

Who is the listed applicant for C-QUR RPM MESH?

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

What is the FDA product code for C-QUR RPM MESH?

The FDA product code for C-QUR RPM MESH is FTL.

Other records listing Atrium Medical Corp. as applicant

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Related Devices (Code: FTL)

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.

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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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