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FDA 510(k)

RADIONICS VARILINK 2

K-Number: K023519 · 2003-01-16

ApplicantRadionics, A Division of Tyco Healthcare Group LP
Decision Date2003-01-16
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADIONICS VARILINK 2 is the device name listed in this FDA 510(k) record. The listed applicant is Radionics, A Division of Tyco Healthcare Group LP. It received FDA 510(k) clearance on 2003-01-16 under 510(k) number K023519. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIONICS VARILINK 2?

RADIONICS VARILINK 2 is a medical device that received FDA 510(k) clearance on 2003-01-16. The listed applicant is Radionics, A Division of Tyco Healthcare Group LP. The 510(k) number is K023519.

When did RADIONICS VARILINK 2 receive FDA 510(k) clearance?

RADIONICS VARILINK 2 received FDA 510(k) clearance on 2003-01-16, under 510(k) number K023519.

Who is the listed applicant for RADIONICS VARILINK 2?

The FDA 510(k) record lists Radionics, A Division of Tyco Healthcare Group LP as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RADIONICS VARILINK 2?

The FDA product code for RADIONICS VARILINK 2 is IYE.

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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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