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FDA 510(k)

THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM)

K-Number: K883412 · 1989-02-08

ApplicantPromedica Products, Inc.
Decision Date1989-02-08
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Promedica Products, Inc.. It received FDA 510(k) clearance on 1989-02-08 under 510(k) number K883412. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM)?

THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM) is a medical device that received FDA 510(k) clearance on 1989-02-08. The listed applicant is Promedica Products, Inc.. The 510(k) number is K883412.

When did THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM) receive FDA 510(k) clearance?

THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM) received FDA 510(k) clearance on 1989-02-08, under 510(k) number K883412.

Who is the listed applicant for THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM)?

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

What is the FDA product code for THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM)?

The FDA product code for THE CARPENTIER TRANS-MITRAL VENTRICULAR VENT(TM) is DWF.

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Other records listing Promedica Products, Inc. as applicant

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Related Devices (Code: DWF)

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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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