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FDA 510(k)

MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE

K-Number: K980016 · 1998-08-07

ApplicantGenzyme Surgical Product (Genzyme Biosurgery)
Decision Date1998-08-07
Product CodeMOP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Surgical Product (Genzyme Biosurgery). It received FDA 510(k) clearance on 1998-08-07 under 510(k) number K980016. 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 MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE?

MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE is a medical device that received FDA 510(k) clearance on 1998-08-07. The listed applicant is Genzyme Surgical Product (Genzyme Biosurgery). The 510(k) number is K980016.

When did MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE receive FDA 510(k) clearance?

MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE received FDA 510(k) clearance on 1998-08-07, under 510(k) number K980016.

Who is the listed applicant for MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE?

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

What is the FDA product code for MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE?

The FDA product code for MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE is MOP.

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Other records listing Genzyme Surgical Product (Genzyme Biosurgery) as applicant

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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.

K974648SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATORSulzer Carbomedics, Inc.K960923CARBOMEDICS MITRAL ROTATORCarbomedics, Inc.K951368CARBOMEDICS EXENDED 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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