Bio Arterial Deluxe (IC-BAP-DX)— 510(k) K250974
Substantially EquivalentBio Compression Systems, Inc.
FDA 510(k) clearance K250974 for Bio Arterial Deluxe (IC-BAP-DX), Substantially Equivalent on 2025-12-12. Applicant: Bio Compression Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio Compression Systems, Inc.
- Product code
- Code JOW
- Device class
- Class 2
- Regulation
- 21 CFR 870.5800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Moonachie, NJ, US
Recent devices under product code JOW
view allMore clearances from Bio Compression Systems, Inc.
view all- K213533 — Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
- K210417 — Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL
- K180248 — VascuEase IC-1200-WH
- K171793 — Sequential Circulator SC-2004FC-OC
- K150953 — Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC
Data sourced from openFDA. This site is unofficial and independent of the FDA.