510(k) clearance
Emboliner Embolic Protection System (EPC-03)
- 510(k) number
- K261715
- Applicant
- Emboline, Inc.
- Decision date
- Sep 8, 2026
- Date received
- May 22, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- PUM
- Device type
- Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
- Device class
- Class II
- Regulation
- 21 CFR 870.1251
- Advisory committee
- Cardiovascular
- Statement or summary
- Summary
- Third party
- N
- Location
- Santa Cruz, CA, US