Name: Predicase
Price: 199 USD

K-number	K213031
Device name	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
Applicant	Zoll Circulation, Inc.
Product code	NCX
Device class	Class II
Decision date	Dec 20, 2021
Decision	Unknown
Regulation	870.5900

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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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

Everything you need for a 510(k) submission. Nothing you don't.