Product code CAO
- Device name
- Airway, Esophageal (Obturator)
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5650
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K971348 | FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM | Green Field Medical Sourcing, Inc. | 1998-02-27 |
| K894032 | EVAC-TUBE | Sharn, Inc. | 1989-08-31 |
| K875226 | ESOPHAGEAL OBTURATOR/TRACHEAL TUBE | Sheridan Catheter Corp. | 1988-01-19 |
| K864200 | VETA/VENTED ESOPHAGEAL TUBE AIRWAY | Cranco Co. | 1987-03-17 |
| K863172 | RESPIRONICS PTL REVIVEEASY | Respironics, Inc. | 1986-11-04 |
| K761195 | ESOPHAGEAL OBTURATION AIRWAY | Mckesson Corp. | 1976-12-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00812277035407 | Curaplex | BOUND TREE MEDICAL, LLC | 2019-08-30 |
| 00812277035391 | Curaplex | BOUND TREE MEDICAL, LLC | 2019-08-30 |
| 00812277035384 | Curaplex | BOUND TREE MEDICAL, LLC | 2019-08-30 |
| 30884521105571 | Shiley | Covidien LP | 2018-05-16 |
| 40884521105578 | Shiley | Covidien LP | 2018-05-16 |
| 20884521103648 | Shiley | Covidien LP | 2018-05-13 |
| 30884521105564 | Shiley | Covidien LP | 2017-10-05 |
| 40884521105561 | Shiley | Covidien LP | 2017-10-05 |
| 10884521211957 | Shiley | Covidien LP | 2017-05-22 |
| 30884521105557 | Shiley | Covidien LP | 2017-05-22 |
| 10884521211933 | Shiley | Covidien LP | 2017-05-10 |
| 30884521103638 | Shiley | Covidien LP | 2017-05-10 |
| 10884521211940 | Shiley | Covidien LP | 2017-05-09 |
| 40884521105530 | Shiley | Covidien LP | 2017-05-09 |
| 40884521105554 | Shiley | Covidien LP | 2017-03-22 |
| 30884521103621 | Shiley | Covidien LP | 2017-03-22 |
| 20884521103631 | Mallinckrodt | Covidien LP | 2015-08-28 |
| 20884521103624 | Mallinckrodt | Covidien LP | 2015-08-28 |
| 10884521103641 | Mallinckrodt | Covidien LP | 2015-08-28 |
| 20884521105574 | Mallinckrodt | Covidien LP | 2015-08-28 |
| 20884521105567 | Mallinckrodt | Covidien LP | 2015-08-28 |
| 10884521103634 | Mallinckrodt | Covidien LP | 2015-08-28 |
| 20884521105550 | Mallinckrodt | Covidien LP | 2015-08-28 |
| 10884521105539 | Mallinckrodt | Covidien LP | 2015-08-28 |
| 10884521105553 | Mallinckrodt | Covidien LP | 2015-08-28 |
| 10884521105560 | Mallinckrodt | Covidien LP | 2015-08-28 |
| 10884521105577 | Mallinckrodt | Covidien LP | 2015-08-28 |
| 20884521105536 | Mallinckrodt | Covidien LP | 2015-08-28 |
| 10884521103627 | Mallinckrodt | Covidien LP | 2015-08-28 |