FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE
K Number: K131964
·
Decision Jul 24, 2013
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
36
Applicant Total
209
Review Days
27
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE
- K Number
- K131964
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.4380
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic, Inc.
- Date Received
- June 27, 2013
- Decision Date
- July 24, 2013
- Product Code
- DWA
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DWA | Control, Pump Speed, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DWA), ordered by most recent decision date.
INSPIRA ART100
FDA 510(k)
FDA Class 2
·Cardiovascular
Anivia SG1000 Pump Console
FDA 510(k)
FDA Class 2
·Cardiovascular
Anivia SG1000 Pump Console
FDA 510(k)
FDA Class 2
·Cardiovascular
Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure
FDA 510(k)
FDA Class 2
·Cardiovascular
CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit
FDA 510(k)
FDA Class 2
·Cardiovascular
CentriMag Acute Circulatory Support System
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Medtronic, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260195 | Elongated One-Piece Arterial (EOPA) 3D Arterial Cannulae | Apr 23, 2026 | Substantially Equivalent |
| K253203 | Retrograde Coronary Sinus Perfusion Cannulae | Feb 19, 2026 | Substantially Equivalent |
| K253998 | Clearview Intracoronary Shunts | Jan 20, 2026 | Substantially Equivalent |
| K251831 | Bio-Medicus Life Support Catheter and Introducer | Jan 15, 2026 | Substantially Equivalent |
| K253511 | Concerto Versa Detachable Coil | Jan 14, 2026 | Substantially Equivalent |
| K253409 | C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) | Dec 19, 2025 | Substantially Equivalent |
| K251258 | MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous Cannula | Jun 20, 2025 | Substantially Equivalent |
| K250075 | Medtronic Stedi Extra Support Guidewire | Jun 13, 2025 | Substantially Equivalent |
| K250199 | VitalFlow Console | May 20, 2025 | Substantially Equivalent |
| K250558 | SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) | Mar 27, 2025 | Substantially Equivalent |