TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support
FDA 510(k) K240948 · Imperative Care, Inc.
510(k) numberK240948
Submission
- Device name
- TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support
- Applicant
- Imperative Care, Inc.
Campbell, CA, US - Received
- April 8, 2024
- Decision date
- June 6, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QJP – Catheter, Percutaneous, Neurovasculature
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
To provide vascular access to the neurovasculature for interventional or diagnostic procedures
Other 510(k)s with product code QJP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262277 | 70 NeuGlide CatheterQJP · Special | Piraeus Medical, Inc. | 09/04/2026SE |
| K261176 | Zoom 4S CatheterQJP · Traditional | Imperative Care, Inc. | 08/28/2026SE |
| K254071 | p17 XR MicrocatheterQJP · Traditional | Wallaby Medical | 08/18/2026SE |
| K260199 | SLIM MicrocatheterQJP · Traditional | Balt USA, LLC | 07/13/2026SE |
| K253901 | Millipede88 Access CatheterQJP · Traditional | Perfuze, Ltd. | 07/09/2026SE |
| K261889 | Trevo Trak 21 MicrocatheterQJP · Special | Stryker Neurovascular | 07/01/2026SE |
| K261808 | ISAAC Neurovascular Navigation CatheterQJP · Special | Microvention Inc. d/b/a Terumo Neuro | 06/30/2026SE |
| K261549 | BOBBY Balloon Guide CatheterQJP · Special | MicroVention, Inc., d/b/a Terumo Neuro | 06/09/2026SE |
| K253359 | Zenith Distal Access Long SheathQJP · Traditional | Suzhou Zenith Vascular SciTech Limited | 05/22/2026SE |
| K254178 | SAYA 86 Radial Access Guide CatheterQJP · Traditional | Asahi Intecc Co., Ltd. | 05/11/2026SE |
More from Asahi Intecc Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K261176 | Zoom 4S CatheterQJP · Traditional | 08/28/2026SE |
| K252046 | Zoom System (Zoom 4S Catheter)NRY · Traditional | 10/30/2025SE |
| K252057 | Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy SystemQEW · Traditional | 08/28/2025SE |
| K244061 | X-Wire GuidewireMOF · Traditional | 08/26/2025SE |
| K243047 | Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration TubingNRY · Traditional | 05/28/2025SE |
| K250775 | Symphony Thrombectomy System; Symphony 16F 82cm Thrombectomy SystemQEW · Special | 05/14/2025SE |
| K242672 | Zoom SystemNRY · Traditional | 01/14/2025SE |
| K233975 | Zoom 6F Insert CathetersDQO · Traditional | 04/02/2024SE |
| K231168 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal…QJP · Special | 05/22/2023SE |
| K220807 | Imperative Care Radial 088 Access SystemQJP · Traditional | 05/17/2022SE |
Questions and answers
When was TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support cleared by the FDA?
TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support (K240948) received a 510(k) decision of Substantially Equivalent on June 6, 2024, 59 days after the submission was received.
What is the product code of K240948?
The FDA product code is QJP – Catheter, Percutaneous, Neurovasculature, a Class II (moderate risk) device regulated under 21 CFR 870.1250.