510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K213031Unknown

Solex 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 Console

ZOLL Circulation, Inc., San Jose CA / Traditional, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213031 is the FDA 510(k) clearance record for Solex 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 Console, a class II device, cleared for Zoll Circulation, Inc. on under FDA product code NCX (System, Hypothermia, Intravenous, Cooling). FDA records list 13 510(k) clearances for Zoll Circulation, Inc., from to . As of , FDA records show no recalls naming K213031.

Clearance record

Decision date
Received
(90 days to decision)
Product code
NCX System, Hypothermia, Intravenous, Cooling
Regulation
21 CFR 870.5900
Device class
Class II
Review panel
Cardiovascular
Applicant
Zoll Circulation, Inc. 200 Ringwood Ave., San Jose 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