K250974
- 510(k) number
- K250974
- Device name
- Bio Arterial Deluxe (IC-BAP-DX)
- Applicant
- Bio Compression Systems, Inc. NJ · US
- Product code
- JOW — Sleeve, Limb, Compressible
- Decision date
- 2025-12-12
- Date received
- 2025-03-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K250974.pdf
Official FDA record: K250974
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.