The following data is part of a premarket notification filed by Bryan Medical , Inc. with the FDA for Aeris Balloon Dialation Catheter.
| Device ID | K150951 |
| 510k Number | K150951 |
| Device Name: | Aeris Balloon Dialation Catheter |
| Classification | Bronchoscope (flexible Or Rigid) |
| Applicant | Bryan Medical , Inc. 3906 Oak St. Cincinnati, OH 45227 |
| Contact | Andy Black |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | EOQ |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-04-09 |
| Decision Date | 2015-06-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| KG1840 | K150951 | 000 |
| KG1640 | K150951 | 000 |
| KG1240 | K150951 | 000 |
| KG1030 | K150951 | 000 |
| KG0930 | K150951 | 000 |
| KG0830 | K150951 | 000 |
| KG0730 | K150951 | 000 |
| KG0630 | K150951 | 000 |
| KG0530 | K150951 | 000 |