FDA.reportPublic FDA data

510(k) K221491

Device
Anivia SG1000 Pump Console
Applicant
Apmtd, Inc.
510(k) number
K221491
Product code
DWA
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-03
Date received
2022-05-23
Regulation
870.4380
Classification name
Control, Pump Speed, Cardiopulmonary Bypass
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
John Sasso
Address
226 Lowell St. Unit B16 Wilmington MA US 01887 01887

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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