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FDA 510(k)

HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC

K-Number: K955349 · 1996-02-14

ApplicantMeadox Medicals, Div. Boston Scientific Corp.
Decision Date1996-02-14
Product CodeDXZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC is the device name listed in this FDA 510(k) record. The listed applicant is Meadox Medicals, Div. Boston Scientific Corp.. It received FDA 510(k) clearance on 1996-02-14 under 510(k) number K955349. 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 HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC?

HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC is a medical device that received FDA 510(k) clearance on 1996-02-14. The listed applicant is Meadox Medicals, Div. Boston Scientific Corp.. The 510(k) number is K955349.

When did HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC receive FDA 510(k) clearance?

HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC received FDA 510(k) clearance on 1996-02-14, under 510(k) number K955349.

Who is the listed applicant for HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC?

The FDA 510(k) record lists Meadox Medicals, Div. Boston Scientific Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC?

The FDA product code for HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC is DXZ.

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Other records listing Meadox Medicals, Div. Boston Scientific 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.

K953647MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATINGK960766MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFTK962433MEADOX EXXCEL EPTFE VASCULAR GRAFTK961847HEMASHIELD VANTAGE (VASCULAR GRAFTK962342HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCHK955460MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFT

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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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