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FDA 510(k)

HEMASHIELD VANTAGE (VASCULAR GRAFT

K-Number: K961847 · 1997-01-22

ApplicantMeadox Medicals, Div. Boston Scientific Corp.
Decision Date1997-01-22
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent - Subject to Tracking Reg.

Device Summary

HEMASHIELD VANTAGE (VASCULAR GRAFT 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 1997-01-22 under 510(k) number K961847. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent - Subject to Tracking Reg..

Frequently Asked Questions

What is the HEMASHIELD VANTAGE (VASCULAR GRAFT?

HEMASHIELD VANTAGE (VASCULAR GRAFT is a medical device that received FDA 510(k) clearance on 1997-01-22. The listed applicant is Meadox Medicals, Div. Boston Scientific Corp.. The 510(k) number is K961847.

When did HEMASHIELD VANTAGE (VASCULAR GRAFT receive FDA 510(k) clearance?

HEMASHIELD VANTAGE (VASCULAR GRAFT received FDA 510(k) clearance on 1997-01-22, under 510(k) number K961847.

Who is the listed applicant for HEMASHIELD VANTAGE (VASCULAR GRAFT?

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 VANTAGE (VASCULAR GRAFT?

The FDA product code for HEMASHIELD VANTAGE (VASCULAR GRAFT is DSY.

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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 GRAFTK962342HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCHK955460MEADOX MEDICALS, INC., EXPANDED & EXTERNALLY SUPPORTED EXPANDED PTFE VASCULAR GRAFTK952884NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATATION CATHETER

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Related Devices (Code: DSY)

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.

K252445Fusion Bioline Vascular GraftMaquet Cardiovascular, LLCK252277Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645)Vascular Flow Technologies LimitedK241550Gelweave™ Vascular ProsthesesVascutek, Ltd.K241070Gelsoft™ Plus Vascular ProsthesesVascutek, Ltd.K231972Advanta VXT Vascular Graft, Flixene Vascular GraftAtrium Medical CorporationK240083GORE® PROPATEN® Vascular GraftW. L. Gore & Associates, Inc.

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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