K252046
- 510(k) number
- K252046
- Device name
- Zoom System (Zoom 4S Catheter)
- Applicant
- Imperative Care, Inc. CA · US
- Product code
- NRY — Catheter, Thrombus Retriever
- Decision date
- 2025-10-30
- Date received
- 2025-06-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252046.pdf
Official FDA record: K252046
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.