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FDA 510(k)

SURTRAK IMPLANTATION KIT

K-Number: K060679 · 2006-04-21

ApplicantNorth American Scientific, Inc.
Decision Date2006-04-21
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SURTRAK IMPLANTATION KIT is the device name listed in this FDA 510(k) record. The listed applicant is North American Scientific, Inc.. It received FDA 510(k) clearance on 2006-04-21 under 510(k) number K060679. 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 SURTRAK IMPLANTATION KIT?

SURTRAK IMPLANTATION KIT is a medical device that received FDA 510(k) clearance on 2006-04-21. The listed applicant is North American Scientific, Inc.. The 510(k) number is K060679.

When did SURTRAK IMPLANTATION KIT receive FDA 510(k) clearance?

SURTRAK IMPLANTATION KIT received FDA 510(k) clearance on 2006-04-21, under 510(k) number K060679.

Who is the listed applicant for SURTRAK IMPLANTATION KIT?

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

What is the FDA product code for SURTRAK IMPLANTATION KIT?

The FDA product code for SURTRAK IMPLANTATION KIT 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 North American Scientific, 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.

K062241ADJUSTABLE MULTI-CATHETER SOURCE APPLICTORK052024NSTRAND IMPLANTATION KITK964647NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE

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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