K243047
- 510(k) number
- K243047
- Device name
- Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing
- Applicant
- Imperative Care, Inc. CA · US
- Product code
- NRY — Catheter, Thrombus Retriever
- Decision date
- 2025-05-28
- Date received
- 2024-09-27
- 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: K243047.pdf
Official FDA record: K243047
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.