FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Bio-Medicus Life Support Catheter and Introducer
K Number: K251831
·
Decision Jan 15, 2026
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
2
Applicant Total
209
Review Days
216
Basic Information
- Device Name
- Bio-Medicus Life Support Catheter and Introducer
- K Number
- K251831
- 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
- June 13, 2025
- Decision Date
- January 15, 2026
- Product Code
- QHW
- 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 |
|---|---|---|---|
| QHW | Single Lumen Ecmo Cannula | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QHW), ordered by most recent decision date.
Bio-Medicus Life Support Catheter and Introducer
FDA 510(k)
FDA Class 2
·Cardiovascular
Bio-Medicus Life Support Catheter and Introducer
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 |
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| 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 |
| K242705 | Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500) | Jan 17, 2025 | Substantially Equivalent |