Bio-Console 560 Extracorporeal Blood Pumping Console
FDA 510(k) K131964 · Medtronic, Inc.
510(k) numberK131964
Submission
- Device name
- Bio-Console 560 Extracorporeal Blood Pumping Console
- Applicant
- Medtronic, Inc.
Mounds View, MN, US - Received
- June 27, 2013
- Decision date
- July 24, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWA – Control, Pump Speed, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4380
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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Questions and answers
When was Bio-Console 560 Extracorporeal Blood Pumping Console cleared by the FDA?
Bio-Console 560 Extracorporeal Blood Pumping Console (K131964) received a 510(k) decision of Substantially Equivalent on July 24, 2013, 27 days after the submission was received.
What is the product code of K131964?
The FDA product code is DWA – Control, Pump Speed, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4380.