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FDA 510(k)

BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH

K-Number: K061314 · 2006-06-02

ApplicantDavol Inc., Sub. C. R. Bard, Inc.
Decision Date2006-06-02
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH is the device name listed in this FDA 510(k) record. The listed applicant is Davol Inc., Sub. C. R. Bard, Inc.. It received FDA 510(k) clearance on 2006-06-02 under 510(k) number K061314. 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 BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH?

BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH is a medical device that received FDA 510(k) clearance on 2006-06-02. The listed applicant is Davol Inc., Sub. C. R. Bard, Inc.. The 510(k) number is K061314.

When did BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH receive FDA 510(k) clearance?

BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH received FDA 510(k) clearance on 2006-06-02, under 510(k) number K061314.

Who is the listed applicant for BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH?

The FDA 510(k) record lists Davol Inc., Sub. C. R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH?

The FDA product code for BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH is FTL.

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Other records listing Davol Inc., Sub. C. R. Bard, Inc. 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.

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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