FDA 510(k) Applications Submitted by Kotei Aoki

FDA 510(k) Number Submission Date Device Name Applicant
K160200 01/28/2016 Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set COOK INCORPORATED
K160542 02/26/2016 5.0 Fr Arndt Endobronchial Blocker Set COOK INCORPORATED
K230752 03/17/2023 Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A) Fujifilm Healthcare Americas Corporation
K171917 06/27/2017 Frova Intubating Introducer Cook Incorporated
K162729 09/29/2016 Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip COOK INCORPORATED
K182832 10/09/2018 Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set Cook Incorporated
K173654 11/28/2017 Ureteral Dilator Sets, Ureteral Dilators Cook Incorporated
K153761 12/30/2015 Emergency Transtracheal Airway Catheter COOK INCORPORATED


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