Better-Venter
FDA 510(k) K961594 · Circulatory Technology, Inc.
510(k) numberK961594
Submission
- Device name
- Better-Venter
- Applicant
- Circulatory Technology, Inc.
Oyster Bay, NY, US - Received
- April 24, 1996
- Decision date
- September 5, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K140321 | Initary Better Bladder-PediatricDTN · Special | 04/17/2014SE |
| K012942 | The V Bag, Catalog Number VB1800; Vac-Box for Vacuum Assisted Venous Drainage, Catalog…DTN · Traditional | 11/05/2001SE |
| K001822 | The V-BagDTN · Traditional | 07/07/2000SE |
| K981284 | Better-Bladder (BB)DTN · Traditional | 08/12/1998SE |
| K964205 | Better-TubingDWF · Traditional | 04/08/1998SE |
| K964337 | Better-Bladder (BB)FIB · Traditional | 05/23/1997SE |
| K941492 | Pressure Relief ValveMNJ · Traditional | 10/26/1994SE |
| K942933 | Pressure Infusion CuffKZD · Traditional | 08/25/1994SE |
Questions and answers
When was Better-Venter cleared by the FDA?
Better-Venter (K961594) received a 510(k) decision of Substantially Equivalent on September 5, 1996, 134 days after the submission was received.
What is the product code of K961594?
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.