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FDA 510(k)

CORONARY ANASTOMOSIS MARKING SYSTEM

K-Number: K832806 · 1983-09-29

ApplicantBiotrac Laboratories
Decision Date1983-09-29
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CORONARY ANASTOMOSIS MARKING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biotrac Laboratories. It received FDA 510(k) clearance on 1983-09-29 under 510(k) number K832806. 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 ANASTOMOSIS MARKING SYSTEM?

CORONARY ANASTOMOSIS MARKING SYSTEM is a medical device that received FDA 510(k) clearance on 1983-09-29. The listed applicant is Biotrac Laboratories. The 510(k) number is K832806.

When did CORONARY ANASTOMOSIS MARKING SYSTEM receive FDA 510(k) clearance?

CORONARY ANASTOMOSIS MARKING SYSTEM received FDA 510(k) clearance on 1983-09-29, under 510(k) number K832806.

Who is the listed applicant for CORONARY ANASTOMOSIS MARKING SYSTEM?

The FDA 510(k) record lists Biotrac Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORONARY ANASTOMOSIS MARKING SYSTEM?

The FDA product code for CORONARY ANASTOMOSIS MARKING SYSTEM 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 Biotrac Laboratories 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.

K843216ECLIPSE HEART SUPPORT FOR CORONARY ARTER

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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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