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FDA 510(k)

CARDIO-WRAP

K-Number: K090637 · 2010-01-07

ApplicantMast Biosurgery USA, Inc.
Decision Date2010-01-07
Product CodeDXZ
Advisory CommitteeCV
DecisionUnknown

Device Summary

CARDIO-WRAP is the device name listed in this FDA 510(k) record. The listed applicant is Mast Biosurgery USA, Inc.. It received FDA 510(k) clearance on 2010-01-07 under 510(k) number K090637. The device is classified under product code DXZ. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the CARDIO-WRAP?

CARDIO-WRAP is a medical device that received FDA 510(k) clearance on 2010-01-07. The listed applicant is Mast Biosurgery USA, Inc.. The 510(k) number is K090637.

When did CARDIO-WRAP receive FDA 510(k) clearance?

CARDIO-WRAP received FDA 510(k) clearance on 2010-01-07, under 510(k) number K090637.

Who is the listed applicant for CARDIO-WRAP?

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

What is the FDA product code for CARDIO-WRAP?

The FDA product code for CARDIO-WRAP is DXZ.

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Other records listing Mast Biosurgery USA, 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.

K063648SURGI-WRAP MAST TENDON SHEETK061473SURGI-WRAP MAST BIORESORBABLE SHEETK050332SURGI-WRAP MAST BIORESORBABLE SHEET

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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