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FDA 510(k)

MITRAL VALVE ORIFICE SIZER

K-Number: K820887 · 1982-07-08

ApplicantCeltech
Decision Date1982-07-08
Product CodeDTI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MITRAL VALVE ORIFICE SIZER is the device name listed in this FDA 510(k) record. The listed applicant is Celtech. It received FDA 510(k) clearance on 1982-07-08 under 510(k) number K820887. 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 MITRAL VALVE ORIFICE SIZER?

MITRAL VALVE ORIFICE SIZER is a medical device that received FDA 510(k) clearance on 1982-07-08. The listed applicant is Celtech. The 510(k) number is K820887.

When did MITRAL VALVE ORIFICE SIZER receive FDA 510(k) clearance?

MITRAL VALVE ORIFICE SIZER received FDA 510(k) clearance on 1982-07-08, under 510(k) number K820887.

Who is the listed applicant for MITRAL VALVE ORIFICE SIZER?

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

What is the FDA product code for MITRAL VALVE ORIFICE SIZER?

The FDA product code for MITRAL VALVE ORIFICE SIZER 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.K852612METRONIC MODEL F7700 HEART VALVE SIZERSMedtronic VascularK801885HANCOCK * OBTURATORSHancock Laboratories, Inc.

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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