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FDA 510(k)

PRIMI AND SECONDI SUPPORT CATHETERS

K-Number: K130850 · 2013-06-25

ApplicantThermopeutix, Inc.
Decision Date2013-06-25
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRIMI AND SECONDI SUPPORT CATHETERS is the device name listed in this FDA 510(k) record. The listed applicant is Thermopeutix, Inc.. It received FDA 510(k) clearance on 2013-06-25 under 510(k) number K130850. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRIMI AND SECONDI SUPPORT CATHETERS?

PRIMI AND SECONDI SUPPORT CATHETERS is a medical device that received FDA 510(k) clearance on 2013-06-25. The listed applicant is Thermopeutix, Inc.. The 510(k) number is K130850.

When did PRIMI AND SECONDI SUPPORT CATHETERS receive FDA 510(k) clearance?

PRIMI AND SECONDI SUPPORT CATHETERS received FDA 510(k) clearance on 2013-06-25, under 510(k) number K130850.

Who is the listed applicant for PRIMI AND SECONDI SUPPORT CATHETERS?

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

What is the FDA product code for PRIMI AND SECONDI SUPPORT CATHETERS?

The FDA product code for PRIMI AND SECONDI SUPPORT CATHETERS is DQY.

Related Clinical Trials

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Other records listing Thermopeutix, 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.

K132701PRIMI SUPPORT CATHETERK112219TAPAS CATHETERK093847DUFLO CATHETER (HEPARIN COATED)K080700DUOFLO CATHETER

Related Devices (Code: DQY)

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.

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott

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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