510(k) clearances

CentriMag™ Acute Circulatory Support System

ABBOTT MEDICAL · Cardiovascular

K234118Substantially EquivalentSpecialQNR
Open FDA's page for this record
Third party flag
N
City
Pleasanton
Advisory committee description
Cardiovascular
Address 1
6035 Stoneridge Dr. Pleasanton
Statement or summary
Summary
Product code
QNR
Zip code
94588
Applicant
ABBOTT MEDICAL
Decision date
2024-01-26
Decision code
SESE
Country code
US
Device name
CentriMag™ Acute Circulatory Support System
Advisory committee
CV
Contact
Bendre Ketaki
K number
K234118
State
CA
Date received
2023-12-28
Review advisory committee
CV
Postal code
94588
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Blood Pump For Ecmo, Long-Term (> 6 Hours) Use
Medical specialty description
Cardiovascular
Regulation number
870.4100
Device class
2
Registration number
2916596, 9611665, 3004593495, 1218444, 3010163695, 2133810, 3011468686, 9617601, 3003306248
FEI number
2916596, 3002807095, 3004593495, 1218444, 3010163695, 3011468686, 3000203066, 3002534070, 3003306248
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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.