510(k) K971421

Device
Bard Isoflow Blood Pump
Applicant
C.R. BARD, INC.
510(k) number
K971421
Product code
DWA
Decision
Substantially Equivalent (SESE)
Decision date
1998-05-14
Date received
1997-04-16
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
SANDRA L PERREAND
Address
25 Computer Dr. Haverhill MA US 01832 01832

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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