Medtronic Bio-Medicus Femoral Cannula/Introducer
FDA 510(k) K924642 · Medtronic Bio-Medicus, Inc.
510(k) numberK924642
Submission
- Device name
- Medtronic Bio-Medicus Femoral Cannula/Introducer
- Applicant
- Medtronic Bio-Medicus, Inc.
Eden Prairie, MN, US - Received
- September 14, 1992
- Decision date
- March 26, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWF – Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4210
- Specialty
- Cardiovascular
Other 510(k)s with product code DWF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260195 | Elongated One-Piece Arterial (EOPA) 3D Arterial CannulaeDWF · Special | Medtronic, Inc. | 04/23/2026SE |
| K250937 | Venous Return CannulaeDWF · Traditional | LivaNova USA, Inc. | 03/11/2026SE |
| K260043 | Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)DWF · Traditional | Smart Reactors | 02/23/2026SE |
| K253203 | Retrograde Coronary Sinus Perfusion CannulaeDWF · Traditional | Medtronic, Inc. | 02/19/2026SE |
| K253671 | Dual Stage Venous CannulaeDWF · Traditional | Sorin Group Italia S.R.L. | 01/30/2026SE |
| K253998 | Clearview Intracoronary ShuntsDWF · Special | Medtronic, Inc. | 01/20/2026SE |
| K253106 | AngioVac CannulaDWF · Special | AngioDynamics, Inc. | 10/24/2025SE |
| K250283 | RAP Femoral Venous CannulaeDWF · Special | LivaNova USA, Inc. | 07/10/2025SE |
| K250610 | Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)DWF · Special | Sorin Group Italia S.R.L. | 06/27/2025SE |
| K251258 | MC2 Two-Stage Venous Cannula; MC2X Three-Stage Venous CannulaDWF · Traditional | Medtronic, Inc. | 06/20/2025SE |
More from Medtronic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K973237 | Css-Cardioplegia Safety SystemDWB · Traditional | 04/27/1998SE |
| K973011 | BPX80 Bio-Pump (BPX80)KFM · Traditional | 02/25/1998SE |
| K954501 | Biotrend Oxygen Saturation & Hematocrit SystemDTY · Traditional | 01/16/1996SE |
| K941922 | Medsat Oxygen Saturation SystemDRY · Traditional | 02/17/1995SE |
| K936091 | Medtronic Bio-Medicus Bio-Console Model 550M Pump Speed ControllerDWA · Traditional | 12/23/1994SE |
| K941921 | Bio-Medicus Bio-Console Models 540, 540A,B,C,D,E, & 550DWA · Traditional | 07/20/1994SE |
| K924208 | Bio-Probe(R) Blood Flow Monitoring SYST(TX-50/50P)DPT · Traditional | 07/08/1993SE |
| K926357 | Medtronic Bio-Medicus Handcrank Model 150DWA · Traditional | 06/02/1993SE |
| K924206 | Medtronic Bio-Medicus Bio-Console Model 540EDWA · Traditional | 05/07/1993SE |
| K924205 | Medtronic Bio-Medicus Bio-Console Model 550DWA · Traditional | 05/06/1993SE |
Questions and answers
When was Medtronic Bio-Medicus Femoral Cannula/Introducer cleared by the FDA?
Medtronic Bio-Medicus Femoral Cannula/Introducer (K924642) received a 510(k) decision of Substantially Equivalent on March 26, 1993, 193 days after the submission was received.
What is the product code of K924642?
The FDA product code is DWF – Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4210.