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FDA 510(k)

CORONARY VEIN GRAFT TAG MARKER

K-Number: K971966 · 1998-01-26

ApplicantMed-Edge, Inc.
Decision Date1998-01-26
Product CodeKPK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CORONARY VEIN GRAFT TAG 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 1998-01-26 under 510(k) number K971966. The device is classified under product code KPK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORONARY VEIN GRAFT TAG MARKER?

CORONARY VEIN GRAFT TAG MARKER is a medical device that received FDA 510(k) clearance on 1998-01-26. The listed applicant is Med-Edge, Inc.. The 510(k) number is K971966.

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

CORONARY VEIN GRAFT TAG MARKER received FDA 510(k) clearance on 1998-01-26, under 510(k) number K971966.

Who is the listed applicant for CORONARY VEIN GRAFT TAG 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 TAG MARKER?

The FDA product code for CORONARY VEIN GRAFT TAG MARKER is KPK.

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.

K882314CORONARY VEIN GRAFT MARKER

Related Devices (Code: KPK)

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.

K895369VOSS GRAFT MARKERVoss Medical ProductsK864919SCANLAN (TM) VEIN/GRAFT HOLDERScanlan Intl., Inc.K864101COOK (R) VEIN GRAFT RING MARKERSCook, Inc.K801637FLUORO-MARK RADIOPAQUE ANATOMICAL MKR.C.R. Bard, Inc.K770802MARKERS, STAINLESS STEELCardio-Surgical, 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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