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FDA 510(k)

CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE

K-Number: K062384 · 2006-11-09

ApplicantIsoray, Inc.
Decision Date2006-11-09
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE is the device name listed in this FDA 510(k) record. The listed applicant is Isoray, Inc.. It received FDA 510(k) clearance on 2006-11-09 under 510(k) number K062384. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE?

CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE is a medical device that received FDA 510(k) clearance on 2006-11-09. The listed applicant is Isoray, Inc.. The 510(k) number is K062384.

When did CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE receive FDA 510(k) clearance?

CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE received FDA 510(k) clearance on 2006-11-09, under 510(k) number K062384.

Who is the listed applicant for CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE?

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

What is the FDA product code for CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE?

The FDA product code for CESIUM-131 STRAND, STRAND PRELOAD, PRELOAD, S-CARTRIDGE is KXK.

Related Clinical Trials

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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Other records listing Isoray, 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.

K132996CESITRX, (LIQUID CESIUM-131 SOLUTION) FOR USE WITH GLIASITE RTSK030162LAWRENCE CSERION, MODEL CS-1

Related Devices (Code: KXK)

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.

K252296OncoPatchOncopatch, Inc.K242818IsoSphereIsoaid, LLCK223465RadianceTx Radionuclide Brachytherapy SourceRadiance Therapeutics, Inc.K221539GammaTileGt Medical TechnologiesK202267Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge NeedlesIsoray Medical, Inc.K193602LV Liberty Vision Model 1 90Yttrium Brachytherapy SourceLv Liberty Vision Corporation

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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