K240948
- 510(k) number
- K240948
- Device name
- TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support
- Applicant
- Imperative Care, Inc. CA · US
- Product code
- QJP — Catheter, Percutaneous, Neurovasculature
- Decision date
- 2024-06-06
- Date received
- 2024-04-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K240948.pdf
Official FDA record: K240948
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.