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FDA 510(k)

VASCUCLEAR PRECISION BIPOLAR

K-Number: K102983 · 2010-11-01

ApplicantSorin Group USA, Inc.
Decision Date2010-11-01
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

VASCUCLEAR PRECISION BIPOLAR is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group USA, Inc.. It received FDA 510(k) clearance on 2010-11-01 under 510(k) number K102983. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VASCUCLEAR PRECISION BIPOLAR?

VASCUCLEAR PRECISION BIPOLAR is a medical device that received FDA 510(k) clearance on 2010-11-01. The listed applicant is Sorin Group USA, Inc.. The 510(k) number is K102983.

When did VASCUCLEAR PRECISION BIPOLAR receive FDA 510(k) clearance?

VASCUCLEAR PRECISION BIPOLAR received FDA 510(k) clearance on 2010-11-01, under 510(k) number K102983.

Who is the listed applicant for VASCUCLEAR PRECISION BIPOLAR?

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

What is the FDA product code for VASCUCLEAR PRECISION BIPOLAR?

The FDA product code for VASCUCLEAR PRECISION BIPOLAR is GEI.

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Other records listing Sorin Group USA, Inc. as applicant

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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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