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FDA 510(k)

HEPATOSTAT SET, MODEL 760X

K-Number: K061796 · 2006-11-02

ApplicantVygon Corp.
Decision Date2006-11-02
Product CodeGAM
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HEPATOSTAT SET, MODEL 760X is the device name listed in this FDA 510(k) record. The listed applicant is Vygon Corp.. It received FDA 510(k) clearance on 2006-11-02 under 510(k) number K061796. The device is classified under product code GAM. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEPATOSTAT SET, MODEL 760X?

HEPATOSTAT SET, MODEL 760X is a medical device that received FDA 510(k) clearance on 2006-11-02. The listed applicant is Vygon Corp.. The 510(k) number is K061796.

When did HEPATOSTAT SET, MODEL 760X receive FDA 510(k) clearance?

HEPATOSTAT SET, MODEL 760X received FDA 510(k) clearance on 2006-11-02, under 510(k) number K061796.

Who is the listed applicant for HEPATOSTAT SET, MODEL 760X?

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

What is the FDA product code for HEPATOSTAT SET, MODEL 760X?

The FDA product code for HEPATOSTAT SET, MODEL 760X is GAM.

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Other records listing Vygon Corp. 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.

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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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