Carotid Bypass Shunt with Sampling Arm
FDA 510(k) K860743 · Clincal Instruments Corp.
510(k) numberK860743
Submission
- Device name
- Carotid Bypass Shunt with Sampling Arm
- Applicant
- Clincal Instruments Corp.
Dudley, MA, US - Received
- February 27, 1986
- Decision date
- May 28, 1986
- 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
| 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 |
|---|---|---|
| K902327 | Embolectomy CatheterDXE · Traditional | 02/25/1991SE |
| K860742 | Carotid Bypass ShuntDWF · Traditional | 05/28/1986SE |
| K852704 | Tweetheart #102 Fetal/Neonatal Heartbeat AnnunciatHGM · Traditional | 11/26/1985SE |
| K844918 | Occlusion & Occlusion-IrrigationDQT · Traditional | 08/05/1985SE |
| K821220 | Multilumen Intravenous Infusion CatheterGBP · Traditional | 07/09/1982SE |
| K790034 | IntroducersDYB · Traditional | 02/01/1979SE |
| K771043 | Swan GanzDYG · Traditional | 12/20/1977SE |
Questions and answers
When was Carotid Bypass Shunt with Sampling Arm cleared by the FDA?
Carotid Bypass Shunt with Sampling Arm (K860743) received a 510(k) decision of Substantially Equivalent on May 28, 1986, 90 days after the submission was received.
What is the product code of K860743?
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.