K864200 is an FDA 510(k) clearance for the VETA/VENTED ESOPHAGEAL TUBE AIRWAY. This device is classified as a Airway, Esophageal (obturator) (Class II - Special Controls, product code CAO).
Submitted by Cranco Co. (Salt Lake City, US). The FDA issued a Cleared decision on March 17, 1987, 141 days after receiving the submission on October 27, 1986.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5650.
| 510(k) Number | K864200 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 1986 |
| Decision Date | March 17, 1987 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | — |
| Product Code | CAO — Airway, Esophageal (obturator) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5650 |