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FDA 510(k)

REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM

K-Number: K071008 · 2007-05-09

ApplicantRadiant Medical
Decision Date2007-05-09
Product CodeNCX
Advisory CommitteeCV
DecisionUnknown

Device Summary

REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY 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 2007-05-09 under 510(k) number K071008. The device is classified under product code NCX. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM?

REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2007-05-09. The listed applicant is Radiant Medical. The 510(k) number is K071008.

When did REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM receive FDA 510(k) clearance?

REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM received FDA 510(k) clearance on 2007-05-09, under 510(k) number K071008.

Who is the listed applicant for REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY 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 REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM?

The FDA product code for REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY 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 SYSTEMK063405REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEMK042388RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBEK024327SETPOINT ENDOVASCULAR TEMPERATURE PROBEK012512SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM

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.

K223746Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ ConsoleZoll Circulation, Inc.K220008Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ ConsoleZoll Circulation, Inc.K213031Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP ConsoleZoll Circulation, Inc.K152946TEMPEDYSeiratherm GmbHK153162HypocoreNovocor Medical Systems, Inc.K153226Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitZoll Circulation, Inc.

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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