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510(k) K051912

COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B by Alsius Corp. — Product Code NCX

Clearance Details

Decision: SESU ()
Decision Date: October 11, 2005
Date Received: July 14, 2005
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: System, Hypothermia, Intravenous, Cooling
Device Class: Class II
Regulation Number: 870.5900
Review Panel: NE
Submission Type

Other clearances by Alsius Corp.

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K060308 — COOLGARD 3000 (April 26, 2006)
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K030421 — ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM (October 23, 2003)
K014241 — COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D (August 1, 2003)

Other clearances for product code NCX

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K152946 — TEMPEDY (September 15, 2016)
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K141139 — SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER (October 3, 2014)
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K080908 — INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM (October 17, 2008)