510(k) clearances

Aventus Clot Management System

Inquis Medical · Anesthesiology

K240426Substantially EquivalentTraditionalCAC
Open FDA's page for this record
Third party flag
N
City
Menlo Park
Advisory committee description
Anesthesiology
Address 1
127 Independence Dr.
Statement or summary
Summary
Product code
CAC
Zip code
94025
Applicant
Inquis Medical
Decision date
2024-05-14
Decision code
SESE
Country code
US
Device name
Aventus Clot Management System
Advisory committee
AN
Contact
Mojgan Sadaat
K number
K240426
State
CA
Date received
2024-02-13
Review advisory committee
CV
Postal code
94025
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Apparatus, Autotransfusion
Medical specialty description
Anesthesiology
Regulation number
868.5830
Device class
2
Registration number
1526534, 3004142400, 1724474, 3010291427, 1718850, 9680425, 3010413216, 2528981, 3004634229, 3006654680, 3019807891, 2029015, 9612051, 9680143, 3031823122, 1836518, 9617787, 9611109, 3010084488, 3010273872, 2032112, 3004365956, 3007923088, 3008810357, 3015219237, 8022032, 8043817, 3010009632, 3004548776, 9615908, 3005012805, 3011175548, 9681630, 3011554160, 3004111573, 3010041511, 3011137372, 1064858, 3011773324, 3011270181 +13 more
FEI number
1526534, 3004142400, 3010291427, 3002807308, 1718850, 3003282181, 1000160458, 3003094851, 3010413216, 2528981, 3004634229, 3003327833, 3006654680, 3007596547, 3019807891, 3031823122, 3002808267, 3003094575, 3010084488, 3010273872, 3004365956, 3007923088, 3008810357, 3015219237, 1000306431, 3002808845, 3010009632, 3004548776, 3005012805, 3011175548, 3003261020, 3011554160, 3004111573, 3010041511, 3005426550, 3008397795, 1000116158, 3011773324, 3001717360, 3011270181 +13 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.