K261176
- 510(k) number
- K261176
- Device name
- Zoom 4S Catheter
- Applicant
- Imperative Care, Inc. CA · US
- Product code
- QJP — Catheter, Percutaneous, Neurovasculature
- Decision date
- 2026-08-28
- Date received
- 2026-04-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K261176.pdf
Official FDA record: K261176
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.