K150951 is an FDA 510(k) clearance for the aeris Balloon Dialation Catheter. This device is classified as a Bronchoscope Accessory (Class II - Special Controls, product code KTI).
Submitted by Bryan Medical, Inc. (Cincinnati, US). The FDA issued a Cleared decision on June 25, 2015, 77 days after receiving the submission on April 9, 2015.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4680. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf)..
| 510(k) Number | K150951 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 09, 2015 |
| Decision Date | June 25, 2015 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | KTI - Bronchoscope Accessory |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4680 |
| Definition | If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf). |