Duns Number:788403103
Device Description: The FloPump 57mL Centrifugal Pump is a device that uses a method other than revolving roll The FloPump 57mL Centrifugal Pump is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or ii) Temporary circulatory bypass for diversion offlow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
Catalog Number
6500S
Brand Name
FloPump
Version/Model Number
6500S
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 13, 2021
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K193663
Product Code
KFM
Product Code Name
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Public Device Record Key
a7148745-cdf5-40b5-b101-282caa8e46e1
Public Version Date
December 14, 2021
Public Version Number
2
DI Record Publish Date
March 12, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |