K241362
- 510(k) number
- K241362
- Device name
- Pounce XL Thrombectomy System (PTS-1011-7F135)
- Applicant
- Surmodics,Inc. MN · US
- Product code
- QEW — Peripheral Mechanical Thrombectomy With Aspiration
- Decision date
- 2024-09-11
- Date received
- 2024-05-14
- 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: K241362.pdf
Official FDA record: K241362
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.