FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Bio-Medicus Life Support Catheter and Introducer
K Number: K201057
·
Decision Jan 14, 2022
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
1
Applicant Total
15
Review Days
633
Basic Information
- Device Name
- Bio-Medicus Life Support Catheter and Introducer
- K Number
- K201057
- 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
- April 21, 2020
- Decision Date
- January 14, 2022
- 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.
View allOther Clearances by Medtronic Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K240880 | VitalFlow Set with Balance Biosurface | Sep 12, 2024 | Substantially Equivalent |
| K241352 | Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B) | Jun 12, 2024 | Substantially Equivalent |
| K240534 | Bio-Medicus Life Support Catheter and Introducer | Apr 19, 2024 | Substantially Equivalent |
| K232321 | FlexCath Contour Steerable Sheath | Oct 31, 2023 | Substantially Equivalent |
| K223168 | Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance Biosurface | Apr 19, 2023 | Substantially Equivalent |
| K230640 | Affinity Fusion Oxygenator System | Apr 6, 2023 | Substantially Equivalent |
| K223508 | Cardioblate Gemini-s 49260 Surgical Ablation Device; Cardioblate Gemini-s 49351 Surgical Ablation Device | Dec 22, 2022 | Substantially Equivalent |
| K201100 | Bio-Medicus Life Support Catheter and Introducer | Jul 15, 2021 | Substantially Equivalent |
| K200074 | O-arm O2 Imaging System | Apr 24, 2020 | Substantially Equivalent |
| K183353 | Telescope Guide Extension Catheter | Mar 22, 2019 | Substantially Equivalent |