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FDA 510(k)

BARD COMPOSITE PROSTHESIS

K-Number: K971745 · 1997-08-06

ApplicantDavol Inc., Sub. C. R. Bard, Inc.
Decision Date1997-08-06
Product CodeFTL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BARD COMPOSITE PROSTHESIS 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 1997-08-06 under 510(k) number K971745. 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 COMPOSITE PROSTHESIS?

BARD COMPOSITE PROSTHESIS is a medical device that received FDA 510(k) clearance on 1997-08-06. The listed applicant is Davol Inc., Sub. C. R. Bard, Inc.. The 510(k) number is K971745.

When did BARD COMPOSITE PROSTHESIS receive FDA 510(k) clearance?

BARD COMPOSITE PROSTHESIS received FDA 510(k) clearance on 1997-08-06, under 510(k) number K971745.

Who is the listed applicant for BARD COMPOSITE PROSTHESIS?

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 COMPOSITE PROSTHESIS?

The FDA product code for BARD COMPOSITE PROSTHESIS is FTL.

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

K101851VENTRALIGHT ST MESHK092032BARD PERFIX LIGHT PLUG, MODELS 0117050, 0117060, 0117070, 0117080, 0117150, 0117160K081010BARD 3DMAX MESHK061754BARD COMPOSITE L/P MESHK061314BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCHK051848SALUTE II DISPOSABLE FIXATION DEVICE, MODELS 0113070, 0113072, 0113073, 0113077, 0113079

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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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