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FDA 510(k)

RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE

K-Number: K042388 · 2004-10-28

ApplicantRadiant Medical
Decision Date2004-10-28
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RADIANT MEDICAL ENDOCATHETER 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 2004-10-28 under 510(k) number K042388. 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 RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE?

RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE is a medical device that received FDA 510(k) clearance on 2004-10-28. The listed applicant is Radiant Medical. The 510(k) number is K042388.

When did RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE receive FDA 510(k) clearance?

RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE received FDA 510(k) clearance on 2004-10-28, under 510(k) number K042388.

Who is the listed applicant for RADIANT MEDICAL ENDOCATHETER 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 RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE?

The FDA product code for RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE is DQY.

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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 SYSTEMK024327SETPOINT ENDOVASCULAR 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, 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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