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FDA 510(k)

CORRESTORE PATCH SYSTEM

K-Number: K031586 · 2003-08-07

ApplicantSomanetics Corp.
Decision Date2003-08-07
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CORRESTORE PATCH SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Somanetics Corp.. It received FDA 510(k) clearance on 2003-08-07 under 510(k) number K031586. 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 CORRESTORE PATCH SYSTEM?

CORRESTORE PATCH SYSTEM is a medical device that received FDA 510(k) clearance on 2003-08-07. The listed applicant is Somanetics Corp.. The 510(k) number is K031586.

When did CORRESTORE PATCH SYSTEM receive FDA 510(k) clearance?

CORRESTORE PATCH SYSTEM received FDA 510(k) clearance on 2003-08-07, under 510(k) number K031586.

Who is the listed applicant for CORRESTORE PATCH SYSTEM?

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

What is the FDA product code for CORRESTORE PATCH SYSTEM?

The FDA product code for CORRESTORE PATCH SYSTEM is DXZ.

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Other records listing Somanetics 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.

K093422VITAL SYNC MODEL 5000 SERIESK091224OXYALERT NIRSENSORS, ACCESSORIES FOR INVOS 5100C SYSTEM, MODELS: IS-C AND IS-SK082327INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100CK080769INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100CK051274INVOS SYSTEMK040162CORRESTORE PATCH SYSTEM

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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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