SELUTION SLR™ 014 PTCA Drug-Eluting Balloon - SEL 2.25x15 014 RX 140 US
2026-09-21
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3015190176 | 3015190176 | MEDALLIANCE, LLC | 1 | N | 2026-01-01 | 4 Jenner Suite 190 Irvine CA US 92618 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00810220870068 | SELUTION SLR™ 014 PTCA Drug-Eluting Balloon - SEL 2.25x15 014 RX 140 US | 800-327-7714 | brandon.casadecalvo@cordis.com |
| 00810220870075 | SELUTION SLR™ 014 PTCA Drug-Eluting Balloon - SEL 2.25x20 014 RX 140 US | 800-327-7714 | brandon.casadecalvo@cordis.com |
| 00810220870082 | SELUTION SLR™ 014 PTCA Drug-Eluting Balloon - SEL 2.25x25 014 RX 140 US | 800-327-7714 | brandon.casadecalvo@cordis.com |
| 00810220870099 | SELUTION SLR™ 014 PTCA Drug-Eluting Balloon - SEL 2.25x30 014 RX 140 US | 800-327-7714 | brandon.casadecalvo@cordis.com |
| 00810220870129 | SELUTION SLR™ 014 PTCA Drug-Eluting Balloon - SEL 2.50x15 014 RX 140 US | 800-327-7714 | brandon.casadecalvo@cordis.com |
| 00810220870136 | SELUTION SLR™ 014 PTCA Drug-Eluting Balloon - SEL 2.50x20 014 RX 140 US | 800-327-7714 | brandon.casadecalvo@cordis.com |
| 00810220870143 | SELUTION SLR™ 014 PTCA Drug-Eluting Balloon - SEL 2.50x25 014 RX 140 US | 800-327-7714 | brandon.casadecalvo@cordis.com |
| 00810220870150 | SELUTION SLR™ 014 PTCA Drug-Eluting Balloon - SEL 2.50x30 014 RX 140 US | 800-327-7714 | brandon.casadecalvo@cordis.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 239342 | 1014883474 | P250041 | SELUTION SLR™ 014 PTCA Drug-Eluting Balloon | OOB | 2026-09-18 |
| 239342 | 1514041609 | ||||
| 239342 | 1531988534 | ||||
| 239342 | 1582562387 |
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