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FDA 510(k)

CARBOMEDICS EXENDED MITRAL ROTATOR

K-Number: K951368 · 1995-06-20

ApplicantCarbomedics, Inc.
Decision Date1995-06-20
Product CodeMOP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARBOMEDICS EXENDED MITRAL ROTATOR is the device name listed in this FDA 510(k) record. The listed applicant is Carbomedics, Inc.. It received FDA 510(k) clearance on 1995-06-20 under 510(k) number K951368. The device is classified under product code MOP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARBOMEDICS EXENDED MITRAL ROTATOR?

CARBOMEDICS EXENDED MITRAL ROTATOR is a medical device that received FDA 510(k) clearance on 1995-06-20. The listed applicant is Carbomedics, Inc.. The 510(k) number is K951368.

When did CARBOMEDICS EXENDED MITRAL ROTATOR receive FDA 510(k) clearance?

CARBOMEDICS EXENDED MITRAL ROTATOR received FDA 510(k) clearance on 1995-06-20, under 510(k) number K951368.

Who is the listed applicant for CARBOMEDICS EXENDED MITRAL ROTATOR?

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 EXENDED MITRAL ROTATOR?

The FDA product code for CARBOMEDICS EXENDED MITRAL ROTATOR is MOP.

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Other records listing Carbomedics, Inc. as applicant

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.

K970375ANNULOFLO SYSTEMK964665VASCUTEK GELWEAVE VASCULAR GRAFT (BIFURCATED CONFIGURATION)K962154CARBOMEDICS HANDLEK960923CARBOMEDICS MITRAL ROTATORK960706VASCUTEK VASCUSOFT PLUS VASCULAR GRAFTK960169CARBOMEDICS VALVE TESTER

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Related Devices (Code: MOP)

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.

K980016MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLEGenzyme Surgical Product (Genzyme Biosurgery)K974648SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATORSulzer Carbomedics, Inc.K960923CARBOMEDICS MITRAL ROTATORCarbomedics, 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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