K162729 is an FDA 510(k) clearance for the Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip. This device is classified as a Stylet, Tracheal Tube (Class I - General Controls, product code BSR).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on August 11, 2017, 316 days after receiving the submission on September 29, 2016.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5790.
| 510(k) Number | K162729 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2016 |
| Decision Date | August 11, 2017 |
| Days to Decision | 316 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | BSR — Stylet, Tracheal Tube |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 868.5790 |