FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance Biosurface
K Number: K223168
·
Decision Apr 19, 2023
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
0
Applicant Total
209
Review Days
190
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Basic Information
- Device Name
- Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance Biosurface
- K Number
- K223168
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic, Inc.
- Date Received
- October 11, 2022
- Decision Date
- April 19, 2023
- Product Code
- QWF
- 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 |
|---|---|---|---|
| QWF | Tubing, Long Term Support Greater Than 6 Hours | 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 |