Zoom System (Zoom 4S Catheter)
Imperative Care, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014590708 | 3014590708 | IMPERATIVE CARE INC. | 1 | Y | 2026-01-01 | 1359 Dell Ave Campbell CA US 95008 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00812212030801 | Ikon 14 Guidewire - "Imperative Care Neurovascular Guidewire-Standard, 0.014"", 300cm " | 1-408-502-7548 | CustomerService@Imperativecare.com |
| 00812212030818 | Ikon 14 Pro Guidewire - "Imperative Care Neurovascular Guidewire-Support, 0.014"", 200cm " | 1-408-502-7548 | CustomerService@Imperativecare.com |
| 00812212030825 | Ikon 14 Pro Guidewire - "Imperative Care Neurovascular Guidewire-Support, 0.014"", 300cm " | 1-408-502-7548 | CustomerService@Imperativecare.com |
| 00812212030832 | Ikon 18 Guidewire - "Imperative Care Neurovascular Guidewire-Standard, 0.018"", 200cm" | 1-408-502-7548 | CustomerService@Imperativecare.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 222489 | 1786681736 | K252057 | Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System | QEW | 2025-08-28 |
| 222489 | 1816352056 | K252046 | Zoom System (Zoom 4S Catheter) | NRY | 2025-10-30 |
| 222489 | 1786211333 | K250775 | Symphony™ Thrombectomy System; Symphony™ 16F 82cm Thrombectomy System | QEW | 2025-05-14 |
| 222489 | 1293545099 | K244061 | X-Wire Guidewire | MOF | 2025-08-26 |
| 222489 | 1432844096 | K243047 | Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing | NRY | 2025-05-28 |
| 222489 | 1177670571 | K242672 | Zoom System | NRY | 2025-01-14 |
| 222489 | 1222088118 | K240948 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support | QJP | 2024-06-06 |
| 222489 | 1419650300 | K233975 | Zoom 6F Insert Catheters | DQO | 2024-04-02 |
| 222489 | 1231386910 | K231168 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support | QJP | 2023-05-22 |
| 222489 | 1320534871 | K223216 | Symphony Thrombectomy System | QEW | 2023-02-23 |
| 222489 | 1038442101 | K220807 | Imperative Care Radial 088 Access System | QJP | 2022-05-17 |
| 222489 | 2001255431 | K214114 | Prodigy Thrombectomy System | QEW | 2022-04-06 |
| 222489 | 1555473834 | K212224 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform | QJP | 2021-09-20 |
| 222489 | 1506555399 | K211476 | ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubing | NRY | 2021-06-08 |
| 222489 | 1453369884 | K210996 | ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing | NRY | 2021-04-23 |
| 222489 | 2033525456 | K203764 | TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform | QJP | 2021-03-03 |
| 222489 | 1616397487 | K202182 | ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing | NRY | 2020-09-02 |
| 222489 | 1162195419 | K183043 | 0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay Reperfusion Catheter, 0.035” ID MantaRay Reperfusion Catheter | NRY | 2019-04-17 |
| 222489 | 1302304708 | K180169 | EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length | DQY | 2018-08-08 |
Imperative Care, Inc.
Imperative Care, Inc.
Imperative Care, Inc.
Imperative Care, Inc.
Imperative Care, Inc.
Imperative Care, Inc.
Imperative Care, Inc.
Imperative Care Inc.
Imperative Care Inc.
Imperative Care Inc.
Imperative Care Inc.
Imperative Care Inc.
Imperative Care Inc.
Imperative Care Inc.
Imperative Care Inc.
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