Name: Predicase
Price: 199 USD

K-number	K223746
Device name	Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console
Applicant	Zoll Circulation, Inc.
Product code	NCX
Device class	Class II
Decision date	Jan 13, 2023
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, Thermogard XP Console, Thermogard HQ Console

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