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FDA 510(k)

BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY

K-Number: K132097 · 2013-09-30

ApplicantBest Medical International, Inc.
Decision Date2013-09-30
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY is the device name listed in this FDA 510(k) record. The listed applicant is Best Medical International, Inc.. It received FDA 510(k) clearance on 2013-09-30 under 510(k) number K132097. 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 BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY?

BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY is a medical device that received FDA 510(k) clearance on 2013-09-30. The listed applicant is Best Medical International, Inc.. The 510(k) number is K132097.

When did BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY receive FDA 510(k) clearance?

BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY received FDA 510(k) clearance on 2013-09-30, under 510(k) number K132097.

Who is the listed applicant for BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY?

The FDA 510(k) record lists Best Medical International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY?

The FDA product code for BEST MULTI-LUMEN BALLOON APPLICATOR FOR BRACHYTHERAPY is JAQ.

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Other records listing Best Medical International, Inc. 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.

K162499Best Instruminal ApplicatorK061638BEST STRAND AND BEST SPACERK043117BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKERK042786BEST MODEL # 81-01 SERIES IR-192 SOURCESK042586BEST BREAST BRACHYTHERAPY APPLICATOR

Related Devices (Code: JAQ)

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.

K262383LumenCare AzureNucletron B.V.K252717MAASTRO Rectal Applicator SetVarian Medical SystemsK251037Rectal ApplicatorNucletron B.V.K252884Guided Aarhus Applicator SetVarian Medical SystemsK250299CT/ MR Tandem and Ovoid SetVarian Medical Systems, Inc.K250289Intracavitary/Interstitial SystemVarian Medical Systems

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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