Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

COOLGARD 3000

K-Number: K060308 · 2006-04-26

ApplicantAlsius Corp.
Decision Date2006-04-26
Product CodeNCX
Advisory CommitteeCV
DecisionUnknown

Device Summary

COOLGARD 3000 is the device name listed in this FDA 510(k) record. The listed applicant is Alsius Corp.. It received FDA 510(k) clearance on 2006-04-26 under 510(k) number K060308. 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 COOLGARD 3000?

COOLGARD 3000 is a medical device that received FDA 510(k) clearance on 2006-04-26. The listed applicant is Alsius Corp.. The 510(k) number is K060308.

When did COOLGARD 3000 receive FDA 510(k) clearance?

COOLGARD 3000 received FDA 510(k) clearance on 2006-04-26, under 510(k) number K060308.

Who is the listed applicant for COOLGARD 3000?

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 COOLGARD 3000?

The FDA product code for COOLGARD 3000 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SYSTEMK052443ICY CATHETER, MODEL IC-3893AK051912COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B

View all 9 devices →

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.

↑