The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, And Cook Airway Exchange Catheter - Extra Firm With Soft Tip.
| Device ID | K162729 |
| 510k 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 |
| Classification | Stylet, Tracheal Tube |
| Applicant | COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 Bloomington, IN 47404 |
| Contact | Kotei Aoki |
| Correspondent | Kotei Aoki COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 Bloomington, IN 47404 |
| Product Code | BSR |
| CFR Regulation Number | 868.5790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-09-29 |
| Decision Date | 2017-08-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002576285 | K162729 | 000 |
| 00827002576278 | K162729 | 000 |
| 00827002576261 | K162729 | 000 |
| 00827002576254 | K162729 | 000 |
| 00827002576247 | K162729 | 000 |
| 00827002576230 | K162729 | 000 |
| 00827002576223 | K162729 | 000 |
| 00827002576216 | K162729 | 000 |