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FDA 510(k)

SMI CARDIOVASCULAR PATCH

K-Number: K122105 · 2012-12-07

ApplicantSolinas Medical, Inc.
Decision Date2012-12-07
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SMI CARDIOVASCULAR PATCH is the device name listed in this FDA 510(k) record. The listed applicant is Solinas Medical, Inc.. It received FDA 510(k) clearance on 2012-12-07 under 510(k) number K122105. 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 SMI CARDIOVASCULAR PATCH?

SMI CARDIOVASCULAR PATCH is a medical device that received FDA 510(k) clearance on 2012-12-07. The listed applicant is Solinas Medical, Inc.. The 510(k) number is K122105.

When did SMI CARDIOVASCULAR PATCH receive FDA 510(k) clearance?

SMI CARDIOVASCULAR PATCH received FDA 510(k) clearance on 2012-12-07, under 510(k) number K122105.

Who is the listed applicant for SMI CARDIOVASCULAR PATCH?

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

What is the FDA product code for SMI CARDIOVASCULAR PATCH?

The FDA product code for SMI CARDIOVASCULAR PATCH is DXZ.

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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

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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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