510(k) clearances

Emboliner Embolic Protection System (EPC-03)

Emboline, Inc. · Cardiovascular

K261715Substantially EquivalentTraditionalPUM
Open FDA's page for this record
Third party flag
N
City
Santa Cruz
Advisory committee description
Cardiovascular
Address 1
2901 Mission St.
Address 2
Bldg. 2
Statement or summary
Summary
Product code
PUM
Zip code
95060
Applicant
Emboline, Inc.
Decision date
2026-09-08
Decision code
SESE
Country code
US
Device name
Emboliner Embolic Protection System (EPC-03)
Advisory committee
CV
Contact
Will Michul
K number
K261715
State
CA
Date received
2026-05-22
Review advisory committee
CV
Postal code
95060
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
Medical specialty description
Cardiovascular
Regulation number
870.1251
Device class
2
Registration number
2124215, 3003678543, 2134265, 3007695959, 3012448339
FEI number
2124215, 3003678543, 3002095335, 3007695959, 3012448339
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.