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FDA 510(k)

ICY CATHETER, MODEL IC-3893A

K-Number: K052443 · 2005-10-17

ApplicantAlsius Corp.
Decision Date2005-10-17
Product CodeNCX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ICY CATHETER, MODEL IC-3893A is the device name listed in this FDA 510(k) record. The listed applicant is Alsius Corp.. It received FDA 510(k) clearance on 2005-10-17 under 510(k) number K052443. 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 ICY CATHETER, MODEL IC-3893A?

ICY CATHETER, MODEL IC-3893A is a medical device that received FDA 510(k) clearance on 2005-10-17. The listed applicant is Alsius Corp.. The 510(k) number is K052443.

When did ICY CATHETER, MODEL IC-3893A receive FDA 510(k) clearance?

ICY CATHETER, MODEL IC-3893A received FDA 510(k) clearance on 2005-10-17, under 510(k) number K052443.

Who is the listed applicant for ICY CATHETER, MODEL IC-3893A?

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 ICY CATHETER, MODEL IC-3893A?

The FDA product code for ICY CATHETER, MODEL IC-3893A is NCX.

Related Clinical Trials

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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 3000K051912COOL 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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