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FDA 510(k)

METRONIC MODEL F7700 HEART VALVE SIZERS

K-Number: K852612 · 1985-09-23

ApplicantMedtronic Vascular
Decision Date1985-09-23
Product CodeDTI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

METRONIC MODEL F7700 HEART VALVE SIZERS is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular. It received FDA 510(k) clearance on 1985-09-23 under 510(k) number K852612. The device is classified under product code DTI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the METRONIC MODEL F7700 HEART VALVE SIZERS?

METRONIC MODEL F7700 HEART VALVE SIZERS is a medical device that received FDA 510(k) clearance on 1985-09-23. The listed applicant is Medtronic Vascular. The 510(k) number is K852612.

When did METRONIC MODEL F7700 HEART VALVE SIZERS receive FDA 510(k) clearance?

METRONIC MODEL F7700 HEART VALVE SIZERS received FDA 510(k) clearance on 1985-09-23, under 510(k) number K852612.

Who is the listed applicant for METRONIC MODEL F7700 HEART VALVE SIZERS?

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

What is the FDA product code for METRONIC MODEL F7700 HEART VALVE SIZERS?

The FDA product code for METRONIC MODEL F7700 HEART VALVE SIZERS is DTI.

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Related Devices (Code: DTI)

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.

K952184CARBOMEDICS SUPRA-ANNULAR VALVE SIZERCarbomedics, Inc.K934951VALVE SIZERCarbomedics, Inc.K881279EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SETBaxter Healthcare CorpK853313DUROMEDICS CARDIAC VALVE SIZER SETHemex Scientific, Inc.K820887MITRAL VALVE ORIFICE SIZERCeltechK801885HANCOCK * OBTURATORSHancock Laboratories, 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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