510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K051912Unknown

Cool Line Catheter Kit, Models Cl-2085B, Cl-2295A; Icy Catheter Kit, Model Ic-3585A; Fortius Catheter Kit, Mod. Fr-5093B

Alsius Corp., Irvine CA / Traditional, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051912 is the FDA 510(k) clearance record for COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B, a class II device, cleared for Alsius Corp. on under FDA product code NCX (System, Hypothermia, Intravenous, Cooling). FDA records list 9 510(k) clearances for Alsius Corp., from to . As of , FDA records show no recalls naming K051912.

Clearance record

Decision date
Received
(89 days to decision)
Product code
NCX System, Hypothermia, Intravenous, Cooling
Regulation
21 CFR 870.5900
Device class
Class II
Review panel
Cardiovascular
Applicant
Alsius Corp. 15770 Laguna Canyon, Suite 150, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NCX

Trailing 12 months

FDA records hold no clearances under product code NCX in the trailing twelve months.

FDA records show no clearances under product code NCX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NCX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260