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FDA 510(k)

THERMOGARD THERMAL REGULATION SYSTEM

K-Number: K063829 · 2007-01-22

ApplicantAlsius Corp.
Decision Date2007-01-22
Product CodeNCX
Advisory CommitteeCV
DecisionUnknown

Device Summary

THERMOGARD THERMAL REGULATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Alsius Corp.. It received FDA 510(k) clearance on 2007-01-22 under 510(k) number K063829. 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 THERMOGARD THERMAL REGULATION SYSTEM?

THERMOGARD THERMAL REGULATION SYSTEM is a medical device that received FDA 510(k) clearance on 2007-01-22. The listed applicant is Alsius Corp.. The 510(k) number is K063829.

When did THERMOGARD THERMAL REGULATION SYSTEM receive FDA 510(k) clearance?

THERMOGARD THERMAL REGULATION SYSTEM received FDA 510(k) clearance on 2007-01-22, under 510(k) number K063829.

Who is the listed applicant for THERMOGARD THERMAL REGULATION SYSTEM?

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

What is the FDA product code for THERMOGARD THERMAL REGULATION SYSTEM?

The FDA product code for THERMOGARD THERMAL REGULATION SYSTEM is NCX.

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Other records listing Alsius Corp. 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.

K081936SOLEX CATHETER, MODEL SL2593K072234THERMOGARD XP THERMAL REGULATION SYSTEMK070161QUATTRO CATHETER MODEL IC4593K060308COOLGARD 3000K052443ICY CATHETER, MODEL IC-3893AK051912COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B

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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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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