Name: Predicase
Price: 199 USD

K-number	K220008
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 HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console
Applicant	Zoll Circulation, Inc.
Product code	NCX
Device class	Class II
Decision date	Jun 2, 2022
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 HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console

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