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FDA 510(k)

CORONARY VEIN GRAFT MARKER

K-Number: K882314 · 1988-08-04

ApplicantMed-Edge, Inc.
Decision Date1988-08-04
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CORONARY VEIN GRAFT MARKER is the device name listed in this FDA 510(k) record. The listed applicant is Med-Edge, Inc.. It received FDA 510(k) clearance on 1988-08-04 under 510(k) number K882314. 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 CORONARY VEIN GRAFT MARKER?

CORONARY VEIN GRAFT MARKER is a medical device that received FDA 510(k) clearance on 1988-08-04. The listed applicant is Med-Edge, Inc.. The 510(k) number is K882314.

When did CORONARY VEIN GRAFT MARKER receive FDA 510(k) clearance?

CORONARY VEIN GRAFT MARKER received FDA 510(k) clearance on 1988-08-04, under 510(k) number K882314.

Who is the listed applicant for CORONARY VEIN GRAFT MARKER?

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

What is the FDA product code for CORONARY VEIN GRAFT MARKER?

The FDA product code for CORONARY VEIN GRAFT MARKER is DSY.

Related Clinical Trials

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.

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Other records listing Med-Edge, 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.

K971966CORONARY VEIN GRAFT TAG MARKER

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

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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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