510(k) clearances

Aventus Thrombectomy System (IM-2100)

Inquis Medical · Cardiovascular

K250668Substantially EquivalentSpecialQEW
Open FDA's page for this record
Third party flag
N
City
Menlo Park
Advisory committee description
Cardiovascular
Address 1
1530 O'Brien Dr.
Address 2
Suite A
Statement or summary
Summary
Product code
QEW
Zip code
94025
Applicant
Inquis Medical
Decision date
2025-03-25
Decision code
SESE
Country code
US
Device name
Aventus Thrombectomy System (IM-2100)
Advisory committee
CV
Contact
Zachary Woodson
K number
K250668
State
CA
Date received
2025-03-05
Review advisory committee
CV
Postal code
94025
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Peripheral Mechanical Thrombectomy With Aspiration
Medical specialty description
Cardiovascular
Regulation number
870.5150
Device class
2
Registration number
3016704395, 3026567963, 3015615738, 1724474, 3020256033, 2020394, 2134265, 3014498720, 2030624, 1048735, 1000121056, 3043869342, 2124215, 3017210488, 3011642792, 3014687026, 3004737415, 2183744, 1000523114, 3008514120, 3019807891, 3004198398, 3011471056, 1225687, 3017823876, 3007695959, 2244478, 9612164, 3031823122, 3006946276, 3004832480, 3004859241, 9616684, 3010273872, 3013944123, 2032098, 3013758550, 3010047454, 3008114965, 3016591327 +34 more
FEI number
3016704395, 3026567963, 3015615738, 3020256033, 2020394, 3003473227, 3014498720, 1048735, 1000121056, 3002806565, 2124215, 3043869342, 3017210488, 3003094851, 3011642792, 3014687026, 3004737415, 2183744, 1000523114, 3008514120, 3019807891, 3004198398, 3011471056, 3017823876, 3002806434, 3007695959, 3031823122, 3006946276, 3004832480, 3004859241, 3010273872, 3013944123, 3013758550, 3010047454, 3003058448, 3008114965, 3016591327, 3014590708, 3004111573, 3010041511 +34 more
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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.