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FDA 510(k)

MEADOX INTRA-AORTIC GRAFT

K-Number: K881283 · 1988-05-26

ApplicantMeadox Medicals, Div. Boston Scientific Corp.
Decision Date1988-05-26
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEADOX INTRA-AORTIC 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 1988-05-26 under 510(k) number K881283. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEADOX INTRA-AORTIC GRAFT?

MEADOX INTRA-AORTIC GRAFT is a medical device that received FDA 510(k) clearance on 1988-05-26. The listed applicant is Meadox Medicals, Div. Boston Scientific Corp.. The 510(k) number is K881283.

When did MEADOX INTRA-AORTIC GRAFT receive FDA 510(k) clearance?

MEADOX INTRA-AORTIC GRAFT received FDA 510(k) clearance on 1988-05-26, under 510(k) number K881283.

Who is the listed applicant for MEADOX INTRA-AORTIC 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 MEADOX INTRA-AORTIC GRAFT?

The FDA product code for MEADOX INTRA-AORTIC 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 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: 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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