Flowguard Catheters & Cannalae
FDA 510(k) K813037 · Advocacy International, Ltd.
510(k) numberK813037
Submission
- Device name
- Flowguard Catheters & Cannalae
- Applicant
- Advocacy International, Ltd.
Mchenry, IL, US - Received
- October 28, 1981
- Decision date
- December 14, 1981
- 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
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| 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 |
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| K855251 | Modification Asahi New Pan-Series HemofiltersKDI · Traditional | 02/04/1986SE |
| K855212 | Asahi Am Series DialyzersFJI · Traditional | 01/21/1986SE |
| K854259 | Sepacell R-500 & Sepacell R-500ACAK · Traditional | 01/08/1986SE |
| K842103 | Toyo Jozo Uric Acid TestKNK · Traditional | 08/12/1984SE |
| K842104 | Toyo Jozo G-Gtp TestJPZ · Traditional | 08/10/1984SE |
| K830231 | Asahi Hollow Fiber Kidneys, Am-SeriesKOC · Traditional | 03/17/1983SE |
| K830183 | Asahi Hollow Fiber Kidneys NR SeriesKOC · Traditional | 03/17/1983SE |
| K823733 | Eiken Kizai Artificial Kidney Blood CirKOC · Traditional | 01/14/1983SE |
Questions and answers
When was Flowguard Catheters & Cannalae cleared by the FDA?
Flowguard Catheters & Cannalae (K813037) received a 510(k) decision of Substantially Equivalent on December 14, 1981, 47 days after the submission was received.
What is the product code of K813037?
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.