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FDA 510(k)

DUROMEDICS CARDIAC VALVE SIZER SET

K-Number: K853313 · 1985-11-01

ApplicantHemex Scientific, Inc.
Decision Date1985-11-01
Product CodeDTI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DUROMEDICS CARDIAC VALVE SIZER SET is the device name listed in this FDA 510(k) record. The listed applicant is Hemex Scientific, Inc.. It received FDA 510(k) clearance on 1985-11-01 under 510(k) number K853313. 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 DUROMEDICS CARDIAC VALVE SIZER SET?

DUROMEDICS CARDIAC VALVE SIZER SET is a medical device that received FDA 510(k) clearance on 1985-11-01. The listed applicant is Hemex Scientific, Inc.. The 510(k) number is K853313.

When did DUROMEDICS CARDIAC VALVE SIZER SET receive FDA 510(k) clearance?

DUROMEDICS CARDIAC VALVE SIZER SET received FDA 510(k) clearance on 1985-11-01, under 510(k) number K853313.

Who is the listed applicant for DUROMEDICS CARDIAC VALVE SIZER SET?

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

What is the FDA product code for DUROMEDICS CARDIAC VALVE SIZER SET?

The FDA product code for DUROMEDICS CARDIAC VALVE SIZER SET 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 CorpK852612METRONIC MODEL F7700 HEART VALVE SIZERSMedtronic VascularK820887MITRAL 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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