510(k) clearances

ACHM30 AtriClip FLEX-Mini LAA Exclusion System

AtriCure, Inc. · General, Plastic Surgery

K263319Substantially EquivalentSpecialPZX
Open FDA's page for this record
Third party flag
N
City
Mason
Advisory committee description
General, Plastic Surgery
Address 1
7555 Innovation Way
Statement or summary
Summary
Product code
PZX
Zip code
45040
Applicant
AtriCure, Inc.
Decision date
2026-10-21
Decision code
SESE
Country code
US
Device name
ACHM30 AtriClip FLEX-Mini LAA Exclusion System
Advisory committee
SU
Contact
Diane Sung
K number
K263319
State
OH
Date received
2026-09-21
Review advisory committee
CV
Postal code
45040
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Left Atrial Appendage Clip, Implantable
Medical specialty description
General, Plastic Surgery
Regulation number
878.4300
Device class
2
Registration number
1720929, 1424263, 3011706110, 1649518, 3015542130, 1450662, 1526711, 3010034260, 2184009, 2015691, 3003139373
FEI number
1720929, 3003015552, 3011706110, 3001236277, 3015542130, 1000116158, 1450662, 1526711, 3010034260, 2015691, 3003139373
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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.