The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Elation Pulmonary Balloon Dilation.
| Device ID | K161392 |
| 510k Number | K161392 |
| Device Name: | Elation Pulmonary Balloon Dilation |
| 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 | 2016-05-19 |
| Decision Date | 2016-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450399016 | K161392 | 000 |
| 10884450198046 | K161392 | 000 |
| 10884450198039 | K161392 | 000 |
| 10884450198022 | K161392 | 000 |
| 10884450198015 | K161392 | 000 |
| 10884450198008 | K161392 | 000 |
| 10884450197995 | K161392 | 000 |
| 10884450197988 | K161392 | 000 |
| 10884450197971 | K161392 | 000 |
| 10884450197964 | K161392 | 000 |
| 10884450198053 | K161392 | 000 |
| 10884450398910 | K161392 | 000 |
| 10884450399009 | K161392 | 000 |
| 00884450398999 | K161392 | 000 |
| 10884450398989 | K161392 | 000 |
| 00884450398975 | K161392 | 000 |
| 10884450398965 | K161392 | 000 |
| 10884450398958 | K161392 | 000 |
| 10884450398941 | K161392 | 000 |
| 10884450398934 | K161392 | 000 |
| 10884450398927 | K161392 | 000 |
| 10884450197957 | K161392 | 000 |