Directflow Kit, 24 FR, Softclamp Kit, 24FR, Straightshot Kit, 23 FR, Straight Tip, Straightshot Kit, 23 FR, Angled Tip
FDA 510(k) K994243 · Heartport, Inc.
510(k) numberK994243
Submission
- Device name
- Directflow Kit, 24 FR, Softclamp Kit, 24FR, Straightshot Kit, 23 FR, Straight Tip, Straightshot Kit, 23 FR, Angled Tip
- Applicant
- Heartport, Inc.
Redwood City, CA, US - Received
- December 16, 1999
- Decision date
- May 5, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K981995 | Quickdraw Venous CannulaDWF · Traditional | 04/20/1999SE |
| K990772 | Directflow Arterial CannulaDWF · Special | 03/23/1999SE |
| K981009 | Heartport Endopulmonary Vent CatheterDWF · Traditional | 09/04/1998SE |
| K974736 | Heartport Direct Aortic Return Cannula with IntroducerDWF · Traditional | 07/15/1998SE |
| K974175 | Heartport Endoaortic Clamp CatheterDWZ · Traditional | 12/16/1997SE |
| K972570 | Heartport Introducer SheathDYB · Traditional | 10/01/1997SE |
| K971291 | Heartport Endoarterial Return CannulaDWF · Traditional | 06/17/1997SE |
| K970496 | Heartport Maze System: Cryoprobe SetOCL · Traditional | 05/09/1997SE |
| K964302 | Heartport Thoracic TrocarDRC · Traditional | 05/09/1997SE |
| K964161 | Heartport Endoaortic ClampDXC · Traditional | 04/04/1997SE |
Questions and answers
When was Directflow Kit, 24 FR, Softclamp Kit, 24FR, Straightshot Kit, 23 FR, Straight Tip, Straightshot Kit, 23 FR, Angled Tip cleared by the FDA?
Directflow Kit, 24 FR, Softclamp Kit, 24FR, Straightshot Kit, 23 FR, Straight Tip, Straightshot Kit, 23 FR, Angled Tip (K994243) received a 510(k) decision of Substantially Equivalent on May 5, 2000, 141 days after the submission was received.
What is the product code of K994243?
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.