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FDA 510(k)

ATRIUM LITE MESH

K-Number: K002093 · 2000-07-24

ApplicantAtrium Medical Corp.
Decision Date2000-07-24
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ATRIUM LITE 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 2000-07-24 under 510(k) number K002093. 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 ATRIUM LITE MESH?

ATRIUM LITE MESH is a medical device that received FDA 510(k) clearance on 2000-07-24. The listed applicant is Atrium Medical Corp.. The 510(k) number is K002093.

When did ATRIUM LITE MESH receive FDA 510(k) clearance?

ATRIUM LITE MESH received FDA 510(k) clearance on 2000-07-24, under 510(k) number K002093.

Who is the listed applicant for ATRIUM LITE 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 ATRIUM LITE MESH?

The FDA product code for ATRIUM LITE MESH is FTL.

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Other records listing Atrium Medical Corp. as applicant

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.

K130131EDRAIN CHEST DRAINAGE SYSTEMK122138ATRIUM FLIXENE IFG VASCULAR GRAFTK121070C-QUR RPM MESHK113112CLEARWAY RX NB CATHETERK102596ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFTK093431CLEARWAY OTW MODEL 85912

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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.

K253956ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)Sofradim ProductionK253125Parietene™ Flat Sheet MeshMedtronic - Sofradim ProductionK251955Onflex™ MeshDavol Inc., Subsidiary of C. R. Bard, Inc.K251557Bard® Mesh; Bard® Mesh Pre-ShapedDavol, Inc.K250869Parietene™ Macroporous Mesh (PPM5050 )Sofradim ProductionK250098Bard Soft Mesh; Bard Soft Mesh Pre-ShapedDavol, 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.

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