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FDA 510(k)

BAERVELDT GLAUCOMA IMPLANT

K-Number: K905129 · 1991-02-11

ApplicantWright Medical Corp.
Decision Date1991-02-11
Product CodeKYF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BAERVELDT GLAUCOMA IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Wright Medical Corp.. It received FDA 510(k) clearance on 1991-02-11 under 510(k) number K905129. The device is classified under product code KYF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAERVELDT GLAUCOMA IMPLANT?

BAERVELDT GLAUCOMA IMPLANT is a medical device that received FDA 510(k) clearance on 1991-02-11. The listed applicant is Wright Medical Corp.. The 510(k) number is K905129.

When did BAERVELDT GLAUCOMA IMPLANT receive FDA 510(k) clearance?

BAERVELDT GLAUCOMA IMPLANT received FDA 510(k) clearance on 1991-02-11, under 510(k) number K905129.

Who is the listed applicant for BAERVELDT GLAUCOMA IMPLANT?

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

What is the FDA product code for BAERVELDT GLAUCOMA IMPLANT?

The FDA product code for BAERVELDT GLAUCOMA IMPLANT is KYF.

Related Clinical Trials

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.

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Other records listing Wright 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.

K901015WRIGHT POCKET DOPPLERS VASCULAR & OBSTETRICK892501WRIGHT MEDICAL FETASAFE

Related Devices (Code: KYF)

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.

K230975Ahmed® Glaucoma Valve Model FP7New World Medical, Inc.K231051Ahmed® Glaucoma Valve Model FP8New World Medical, Inc.K220032iStent infinite Trabecular Micro-Bypass System, Model iS3Glaukos CorporationK182518AHMED ClearPath Glaucoma Drainage DeviceNew World Medical, Inc.K171451Ahmed Glaucoma Valve Model FP8New World Medical, Inc.K161457XEN Glaucoma Treatment SystemAllergan, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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