The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Elation Pulmonary Balloon Dilation Catheter.
| Device ID | K213434 |
| 510k Number | K213434 |
| Device Name: | Elation Pulmonary Balloon Dilation Catheter |
| Classification | Bronchoscope Accessory |
| Applicant | Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Contact | David Thomas |
| Correspondent | David Thomas Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095 |
| Product Code | KTI |
| CFR Regulation Number | 874.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-22 |
| Decision Date | 2022-03-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450593834 | K213434 | 000 |