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FDA 510(k)

SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM

K-Number: K012512 · 2002-06-11

ApplicantRadiant Medical
Decision Date2002-06-11
Product CodeNCX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Radiant Medical. It received FDA 510(k) clearance on 2002-06-11 under 510(k) number K012512. The device is classified under product code NCX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM?

SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2002-06-11. The listed applicant is Radiant Medical. The 510(k) number is K012512.

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

SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM received FDA 510(k) clearance on 2002-06-11, under 510(k) number K012512.

Who is the listed applicant for SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM?

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 MANAGEMENT SYSTEM?

The FDA product code for SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM is NCX.

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 PROBEK024327SETPOINT ENDOVASCULAR TEMPERATURE PROBE

Related Devices (Code: NCX)

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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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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