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FDA 510(k)

CORONARY ARTERY BYPASS GRAFT (CABG) MARKER

K-Number: K871110 · 1987-08-27

Decision Date1987-08-27
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CORONARY ARTERY BYPASS GRAFT (CABG) MARKER is the device name listed in this FDA 510(k) record. The listed applicant is Edward Weck, Inc.. It received FDA 510(k) clearance on 1987-08-27 under 510(k) number K871110. 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 ARTERY BYPASS GRAFT (CABG) MARKER?

CORONARY ARTERY BYPASS GRAFT (CABG) MARKER is a medical device that received FDA 510(k) clearance on 1987-08-27. The listed applicant is Edward Weck, Inc.. The 510(k) number is K871110.

When did CORONARY ARTERY BYPASS GRAFT (CABG) MARKER receive FDA 510(k) clearance?

CORONARY ARTERY BYPASS GRAFT (CABG) MARKER received FDA 510(k) clearance on 1987-08-27, under 510(k) number K871110.

Who is the listed applicant for CORONARY ARTERY BYPASS GRAFT (CABG) MARKER?

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

What is the FDA product code for CORONARY ARTERY BYPASS GRAFT (CABG) MARKER?

The FDA product code for CORONARY ARTERY BYPASS GRAFT (CABG) 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.

Other records listing Edward Weck, 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.

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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.

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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