Michler-Kapp Cardiovascular Vent Catheter
FDA 510(k) K200289 · Kapp Surgical Instrument, Inc.
510(k) numberK200289
Submission
- Device name
- Michler-Kapp Cardiovascular Vent Catheter
- Applicant
- Kapp Surgical Instrument, Inc.
Warrensville, OH, US - Received
- February 5, 2020
- Decision date
- January 28, 2021
- 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 |
|---|---|---|
| K072216 | Kapp Bari-Ring Endoscopic Marker, Model K-9536NEU · Special | 11/09/2007SE |
| K050384 | Kapp Bari-Ring, Model KS-BR-2005NEU · Traditional | 01/13/2006SE |
| K050657 | Mondeal Contour Ho SystemHRS · Traditional | 08/08/2005SE |
| K050655 | Mondeal Radius Ho System, Model KS-MR-2005HRS · Traditional | 08/08/2005SE |
| K033930 | Kapp Custom Ulnar Head Wrist ImplantKXE · Traditional | 07/28/2004SE |
| K030237 | Kapp Custom Radial Head Elbow ImplantKWI · Traditional | 08/29/2003SE |
| K844177 | Cosgrove Mitral Valve RetractorGAD · Traditional | 11/08/1984SE |
| K843368 | Kapp Spinal ButtonHTN · Traditional | 09/12/1984SE |
Questions and answers
When was Michler-Kapp Cardiovascular Vent Catheter cleared by the FDA?
Michler-Kapp Cardiovascular Vent Catheter (K200289) received a 510(k) decision of Substantially Equivalent on January 28, 2021, 358 days after the submission was received.
What is the product code of K200289?
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.