Name: Predicase
Price: 199 USD

K-number	K162729
Device name	Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip
Applicant	Cook Incorporated
Product code	BSR
Device class	Class I
Decision date	Aug 11, 2017
Decision	Substantially Equivalent
Regulation	868.5790

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip

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