Guiding Catheter (Tip Softness Change)
FDA 510(k) K883981 · Devices For Vascular Intervention, Inc.
510(k) numberK883981
Submission
- Device name
- Guiding Catheter (Tip Softness Change)
- Applicant
- Devices For Vascular Intervention, Inc.
Redwood City, CA, US - Received
- September 21, 1988
- Decision date
- November 3, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
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|---|---|---|---|
| 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 |
|---|---|---|
| K935929 | MicrotrackMCW · Traditional | 03/10/1994SE |
| K920707 | Hollow Motor Drive Unit W/ Torque ControllerMCW · Traditional | 11/23/1992SE |
| K914422 | Devices for Vascu Intervent Rotat Hemostat ValveDQY · Traditional | 12/18/1991SE |
| K911678 | Rotating Hemostatic ValveDYB · Traditional | 07/12/1991SE |
| K910205 | LP-60 Low Pressure Inflation DeviceMAV · Traditional | 02/25/1991SE |
| K901601 | Hollow Motor Drive UnitLIT · Traditional | 07/06/1990SE |
| K883933 | Introducing CatheterDYB · Traditional | 12/02/1988SE |
| K883916 | Rotating Hemostatic ValveDQY · Traditional | 10/28/1988SE |
| K883346 | Simpson Peripheral Atherocath W/Addit. Size 13FLIT · Traditional | 09/26/1988SE |
| K881088 | Addition of a Tip Guard to the Atherocath(Tm)LIT · Traditional | 05/31/1988SE |
Questions and answers
When was Guiding Catheter (Tip Softness Change) cleared by the FDA?
Guiding Catheter (Tip Softness Change) (K883981) received a 510(k) decision of Substantially Equivalent on November 3, 1988, 43 days after the submission was received.
What is the product code of K883981?
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.