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FDA 510(k)

ASCEND BLUE AC MESH; ASCEND BLUE PC MESH

K-Number: K101462 · 2010-08-16

ApplicantCaldera Medical, Inc.
Decision Date2010-08-16
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ASCEND BLUE AC MESH; ASCEND BLUE PC MESH is the device name listed in this FDA 510(k) record. The listed applicant is Caldera Medical, Inc.. It received FDA 510(k) clearance on 2010-08-16 under 510(k) number K101462. 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 ASCEND BLUE AC MESH; ASCEND BLUE PC MESH?

ASCEND BLUE AC MESH; ASCEND BLUE PC MESH is a medical device that received FDA 510(k) clearance on 2010-08-16. The listed applicant is Caldera Medical, Inc.. The 510(k) number is K101462.

When did ASCEND BLUE AC MESH; ASCEND BLUE PC MESH receive FDA 510(k) clearance?

ASCEND BLUE AC MESH; ASCEND BLUE PC MESH received FDA 510(k) clearance on 2010-08-16, under 510(k) number K101462.

Who is the listed applicant for ASCEND BLUE AC MESH; ASCEND BLUE PC MESH?

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

What is the FDA product code for ASCEND BLUE AC MESH; ASCEND BLUE PC MESH?

The FDA product code for ASCEND BLUE AC MESH; ASCEND BLUE PC MESH is FTL.

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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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