510(k) clearance
Sequential Circulator (SC-4004-DL, SC-4008-DL)
- 510(k) number
- K261807
- Applicant
- Bio Compression Systems, Inc.
- Decision date
- Sep 11, 2026
- Date received
- Jun 1, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- JOW
- Device type
- Sleeve, Limb, Compressible
- Device class
- Class II
- Regulation
- 21 CFR 870.5800
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Moonachie, NJ, US