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FDA 510(k)

SETPOINT ENDOVASCULAR TEMPERATURE PROBE

K-Number: K024327 · 2003-03-25

ApplicantRadiant Medical
Decision Date2003-03-25
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SETPOINT ENDOVASCULAR TEMPERATURE PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Radiant Medical. It received FDA 510(k) clearance on 2003-03-25 under 510(k) number K024327. 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 SETPOINT ENDOVASCULAR TEMPERATURE PROBE?

SETPOINT ENDOVASCULAR TEMPERATURE PROBE is a medical device that received FDA 510(k) clearance on 2003-03-25. The listed applicant is Radiant Medical. The 510(k) number is K024327.

When did SETPOINT ENDOVASCULAR TEMPERATURE PROBE receive FDA 510(k) clearance?

SETPOINT ENDOVASCULAR TEMPERATURE PROBE received FDA 510(k) clearance on 2003-03-25, under 510(k) number K024327.

Who is the listed applicant for SETPOINT ENDOVASCULAR TEMPERATURE PROBE?

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

What is the FDA product code for SETPOINT ENDOVASCULAR TEMPERATURE PROBE?

The FDA product code for SETPOINT ENDOVASCULAR TEMPERATURE PROBE is DQY.

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 Radiant Medical 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.

K071358REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEMK071008REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEMK063405REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEMK042388RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBEK012512SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM

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, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK262240SSPC NXT 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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