K241711
- 510(k) number
- K241711
- Device name
- Oscar Peripheral Multifunctional Catheter system
- Applicant
- Biotronik, Inc. OR · US
- Product code
- LIT — Catheter, Angioplasty, Peripheral, Transluminal
- Decision date
- 2024-07-11
- Date received
- 2024-06-14
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K241711.pdf
Official FDA record: K241711
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.