The following data is part of a premarket notification filed by Cook, Inc. with the FDA for Melker Cuffed Emergency Cricothyrotomy Catheter.
| Device ID | K010016 |
| 510k Number | K010016 |
| Device Name: | MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER |
| Classification | Needle, Emergency Airway |
| Applicant | COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington, IN 47402 |
| Contact | Lisa Hopkins |
| Correspondent | Lisa Hopkins COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 Bloomington, IN 47402 |
| Product Code | BWC |
| CFR Regulation Number | 868.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-02 |
| Decision Date | 2001-10-09 |