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FDA 510(k)

CARBOMEDICS SUPRA-ANNULAR VALVE SIZER

K-Number: K952184 · 1995-11-29

ApplicantCarbomedics, Inc.
Decision Date1995-11-29
Product CodeDTI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARBOMEDICS SUPRA-ANNULAR VALVE SIZER is the device name listed in this FDA 510(k) record. The listed applicant is Carbomedics, Inc.. It received FDA 510(k) clearance on 1995-11-29 under 510(k) number K952184. 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 CARBOMEDICS SUPRA-ANNULAR VALVE SIZER?

CARBOMEDICS SUPRA-ANNULAR VALVE SIZER is a medical device that received FDA 510(k) clearance on 1995-11-29. The listed applicant is Carbomedics, Inc.. The 510(k) number is K952184.

When did CARBOMEDICS SUPRA-ANNULAR VALVE SIZER receive FDA 510(k) clearance?

CARBOMEDICS SUPRA-ANNULAR VALVE SIZER received FDA 510(k) clearance on 1995-11-29, under 510(k) number K952184.

Who is the listed applicant for CARBOMEDICS SUPRA-ANNULAR VALVE SIZER?

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

What is the FDA product code for CARBOMEDICS SUPRA-ANNULAR VALVE SIZER?

The FDA product code for CARBOMEDICS SUPRA-ANNULAR VALVE SIZER is DTI.

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Other records listing Carbomedics, Inc. as applicant

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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.

K934951VALVE SIZERCarbomedics, Inc.K881279EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SETBaxter Healthcare CorpK853313DUROMEDICS CARDIAC VALVE SIZER SETHemex Scientific, Inc.K852612METRONIC 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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