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FDA 510(k)

FLUORO-TEX SURGICAL MEMBRANE

K-Number: K973178 · 1997-11-24

ApplicantBridger Biomed, Inc.
Decision Date1997-11-24
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLUORO-TEX SURGICAL MEMBRANE is the device name listed in this FDA 510(k) record. The listed applicant is Bridger Biomed, Inc.. It received FDA 510(k) clearance on 1997-11-24 under 510(k) number K973178. The device is classified under product code DXZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLUORO-TEX SURGICAL MEMBRANE?

FLUORO-TEX SURGICAL MEMBRANE is a medical device that received FDA 510(k) clearance on 1997-11-24. The listed applicant is Bridger Biomed, Inc.. The 510(k) number is K973178.

When did FLUORO-TEX SURGICAL MEMBRANE receive FDA 510(k) clearance?

FLUORO-TEX SURGICAL MEMBRANE received FDA 510(k) clearance on 1997-11-24, under 510(k) number K973178.

Who is the listed applicant for FLUORO-TEX SURGICAL MEMBRANE?

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

What is the FDA product code for FLUORO-TEX SURGICAL MEMBRANE?

The FDA product code for FLUORO-TEX SURGICAL MEMBRANE is DXZ.

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Other records listing Bridger Biomed, 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.

K003906MODIFICATION TO FLUROTEX SURGICAL MESHK003917MODIFICATION TO FLUOROTEX II SURGICAL MESHK002351FLUOROTEX II SURGICAL MESHK994032FLUORO-TEX CARDIOVASCULAR PATCHK984197FLUOROTEX SURGICAL MESHK980548DURA-PATCH MODEL DP-XXX

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Related Devices (Code: DXZ)

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.

K240775PeriBeam® Pericardial MembraneTamabioK200955Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid PatchVascutek, Ltd.K162506PhotoFix Decellularized Bovine PericardiumCryolife, Inc.K162579VascuCelAdmedus Regen Pty, Ltd.K152127CorMatrix TykeCormatrix Cardiovascular, Inc.K122306SYNOVIS COLLAGEN MATRIX (TBD)Synovis Surgical Innovations

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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