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FDA 510(k)

COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D

K-Number: K014241 · 2003-08-01

ApplicantAlsius Corp.
Decision Date2003-08-01
Product CodeNCX
Advisory CommitteeCV
DecisionUnknown

Device Summary

COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D is the device name listed in this FDA 510(k) record. The listed applicant is Alsius Corp.. It received FDA 510(k) clearance on 2003-08-01 under 510(k) number K014241. 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, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D?

COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D is a medical device that received FDA 510(k) clearance on 2003-08-01. The listed applicant is Alsius Corp.. The 510(k) number is K014241.

When did COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D receive FDA 510(k) clearance?

COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D received FDA 510(k) clearance on 2003-08-01, under 510(k) number K014241.

Who is the listed applicant for COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D?

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, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D?

The FDA product code for COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D is NCX.

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Related Devices (Code: NCX)

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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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