2141980DE04
| Company | Shanghai MicroPort Medical (Group) Co., Ltd. | |
| Address | 501 Newton Road ZJ Hi-Tech Park 201203 Shanghai PEOPLE’S REPUBLIC OF CHINA | |
| Regulation | Directive 93/42/EEC on Medical devices, Annex II (4) | |
| Product | Rapamycin Eluting Coronary Stent Systems | |
| FirehawkTM Rapamycin Target Eluting Coronary Stent System | ||
| Model Numbers / Stent ID (mm) x Stent Length (mm) RV2208 2.25 x 8 RV2508 2.5 x 8 RV2708 2.75 x 8 RV3008 3.0 x 8 RV3508 3.5 x 8 RV4008 4.0 x 8 RV2213 2.25 x 13 RV2513 2.5 x 13 RV2713 2.75 x 13 RV3013 3.0 x 13 RV3513 3.5 x 13 RV4013 4.0 x 13 RV2216 2.25 x 16 RV2516 2.5 x 16 RV2716 2.75 x 16 RV3016 3.0 x 16 RV3516 3.5 x 16 RV4016 4.0 x 16 | Model Numbers / Stent ID (mm) x Stent Length (mm) RV2218 2.25 x 18 RV2518 2.5 x 18 RV2718 2.75 x 18 RV3018 3.0 x 18 RV3518 3.5 x 18 RV4018 4.0 x 18 RV2221 2.25 x 21 RV2521 2.5 x 21 RV2721 2.75 x 21 RV3021 3.0 x 21 RV3521 3.5 x 21 RV4021 4.0 x 21 RV2223 2.25 x 23 RV2523 2.5 x 23 RV2723 2.75 x 23 RV3023 3.0 x 23 RV3523 3.5 x 23 RV4023 4.0 x 23 | |
| Firehawk LibertyTM Rapamycin Target Eluting Coronary Stent System | ||
| Model Numbers / Stent ID (mm) x Stent Length (mm) FR2208 2.25 x 8 FR2508 2.5 x 8 FR2708 2.75 x 8 FR3008 3.0 x 8 FR3508 3.5 x 8 FR4008 4.0 x 8 FR2213 2.25 x 13 FR2513 2.5 x 13 FR2713 2.75 x 13 FR3013 3.0 x 13 FR3513 3.5 x 13 FR4013 4.0 x 13 FR2216 2.25 x 16 FR2516 2.5 x 16 FR2716 2.75 x 16 FR3016 3.0 x 16 FR3516 3.5 x 16 FR4016 4.0 x 16 | Model Numbers / Stent ID (mm) x Stent Length (mm) FR2218 2.25 x 18 FR2518 2.5 x 18 FR2718 2.75 x 18 FR3018 3.0 x 18 FR3518 3.5 x 18 FR4018 4.0 x 18 FR2221 2.25 x 21 FR2521 2.5 x 21 FR2721 2.75 x 21 FR3021 3.0 x 21 FR3521 3.5 x 21 FR4021 4.0 x 21 FR2223 2.25 x 23 FR2523 2.5 x 23 FR2723 2.75 x 23 FR3023 3.0 x 23 FR3523 3.5 x 23 FR4023 4.0 x 23 | |
| Firehawk LibertyTM Rapamycin Target Eluting Coronary Stent System | ||
| Model Numbers / Stent ID (mm) x Stent Length (mm) FR2226 2.25 x 26 FR2526 2.5 x 26 FR2726 2.75 x 26 FR3026 3.0 x 26 FR3526 3.5 x 26 FR4026 4.0 x 26 FR2229 2.25 x 29 FR2529 2.5 x 29 FR2729 2.75 x 29 FR3029 3.0 x 29 FR3529 3.5 x 29 FR4029 4.0 x 29 | Model Numbers / Stent ID (mm) x Stent Length (mm) FR2531 2.5 x 31 FR2731 2.75 x 31 FR3031 3.0 x 31 FR3531 3.5 x 31 FR4031 4.0 x 31 FR2533 2.5 x 33 FR2733 2.75 x 33 FR3033 3.0 x 33 FR3533 3.5 x 33 FR4033 4.0 x 33 | |
| Firehawk LibertyTM Rapamycin Target Eluting Coronary Stent System | ||
| Model Numbers / Stent ID (mm) x Stent Length (mm) FR2735 2.75 x 35 FR3035 3.0 x 35 FR3535 3.5 x 35 FR4035 4.0 x 35 | Model Numbers / Stent ID (mm) x Stent Length (mm) FR2738 2.75 x 38 FR3038 3.0 x 38 FR3538 3.5 x 38 FR4038 4.0 x 38 | |
| Status | Valid | |