Elation Pulmonary Balloon Dilation Catheter
FDA 510(k) clearance K213434 · decided 2022-03-08
Clearance details
- K-number
- K213434
- Device name
- Elation Pulmonary Balloon Dilation Catheter
- Applicant
- Merit Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-10-22
- Decision date
- 2022-03-08
- Days to decision
- 137 days
- Clearance type
- Traditional
- Product code
- KTI
- Device class
- 2
- Regulation number
- 874.4680
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- South Jordan, UT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| WRAPSODY® Cell-Impermeable Endoprosthesis (P240023/S004) | Merit Medical Systems, Inc. | 2025-12-11 |
| WRAPSODY Cell-Impermeable Endoprosthesis (P240023/S001) | Merit Medical Systems, Inc. | 2025-02-12 |
| WRAPSODY Cell-Impermeable Endoprosthesis (P240023/S002) | Merit Medical Systems, Inc. | 2025-02-12 |
| WRAPSODY® Cell-Impermeable Endoprosthesis (P240023) | Merit Medical Systems, Inc. | 2024-12-19 |