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FDA 510(k)

ECLIPSE HEART SUPPORT FOR CORONARY ARTER

K-Number: K843216 · 1984-09-20

ApplicantBiotrac Laboratories
Decision Date1984-09-20
Product CodeGAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ECLIPSE HEART SUPPORT FOR CORONARY ARTER is the device name listed in this FDA 510(k) record. The listed applicant is Biotrac Laboratories. It received FDA 510(k) clearance on 1984-09-20 under 510(k) number K843216. The device is classified under product code GAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECLIPSE HEART SUPPORT FOR CORONARY ARTER?

ECLIPSE HEART SUPPORT FOR CORONARY ARTER is a medical device that received FDA 510(k) clearance on 1984-09-20. The listed applicant is Biotrac Laboratories. The 510(k) number is K843216.

When did ECLIPSE HEART SUPPORT FOR CORONARY ARTER receive FDA 510(k) clearance?

ECLIPSE HEART SUPPORT FOR CORONARY ARTER received FDA 510(k) clearance on 1984-09-20, under 510(k) number K843216.

Who is the listed applicant for ECLIPSE HEART SUPPORT FOR CORONARY ARTER?

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 ECLIPSE HEART SUPPORT FOR CORONARY ARTER?

The FDA product code for ECLIPSE HEART SUPPORT FOR CORONARY ARTER is GAD.

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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.

K832806CORONARY ANASTOMOSIS MARKING SYSTEM

Related Devices (Code: GAD)

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.

K152538JRP Wound SpreaderJ.R. Parker, LLCK151104OTELO LLSpineartK132645THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADESMedtronic, Inc.K071775DASHEzsurgicalK050256APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTORApple Medical Corp.K043602QUADRANT RETRACTOR SYSTEMMedtronic Sofamor Danek

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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