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FDA 510(k)

RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE

K-Number: K120344 · 2012-05-03

ApplicantRadiadyne, LLC (Specification Developer)
Decision Date2012-05-03
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Radiadyne, LLC (Specification Developer). It received FDA 510(k) clearance on 2012-05-03 under 510(k) number K120344. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE?

RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE is a medical device that received FDA 510(k) clearance on 2012-05-03. The listed applicant is Radiadyne, LLC (Specification Developer). The 510(k) number is K120344.

When did RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE receive FDA 510(k) clearance?

RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE received FDA 510(k) clearance on 2012-05-03, under 510(k) number K120344.

Who is the listed applicant for RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE?

The FDA 510(k) record lists Radiadyne, LLC (Specification Developer) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE?

The FDA product code for RADIAPAK BRACHYTHERAPY APPLICATOR BALLOON DEVICE is JAQ.

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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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