Emboliner Embolic Protection System (EPC-03)— 510(k) K261715
Substantially EquivalentEmboline, Inc.
FDA 510(k) clearance K261715 for Emboliner Embolic Protection System (EPC-03), Substantially Equivalent on 2026-09-08. Applicant: Emboline, Inc.. Device class: 2.
Summary
The Emboliner Embolic Protection System (EPC-03) is from Emboline, filed under PUM, temporary embolic protection catheters for transcatheter intracardiac procedures. The record doesn't describe it beyond the model number and the code name.
Class II, 21 CFR 870.1251. Cardiovascular is both the classification panel and the review panel. It was a Traditional 510(k).
Emboline filed from Santa Cruz, California. The decision came 109 calendar days after FDA received it (May 22 to September 8, 2026).
Clearance details
- Applicant
- Emboline, Inc.
- Product code
- Product code PUM
- Device class
- Class 2
- Regulation
- 21 CFR 870.1251
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Cruz, CA, US
Recent devices under product code PUM
view allAdverse events under product code PUM
product code PUM- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.