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FDA 510(k)

ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM

K-Number: K030421 · 2003-10-23

ApplicantAlsius Corp.
Decision Date2003-10-23
Product CodeNCX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ALSIUS COOLGARD 3000 & ALSIUS CATHETER 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 2003-10-23 under 510(k) number K030421. 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 ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM?

ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM is a medical device that received FDA 510(k) clearance on 2003-10-23. The listed applicant is Alsius Corp.. The 510(k) number is K030421.

When did ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM receive FDA 510(k) clearance?

ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM received FDA 510(k) clearance on 2003-10-23, under 510(k) number K030421.

Who is the listed applicant for ALSIUS COOLGARD 3000 & ALSIUS CATHETER 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 ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM?

The FDA product code for ALSIUS COOLGARD 3000 & ALSIUS CATHETER 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 IC4593K063829THERMOGARD THERMAL REGULATION SYSTEMK060308COOLGARD 3000K052443ICY CATHETER, MODEL IC-3893A

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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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