Churchill Inter-Cardiac Sucker
FDA 510(k) K872043 · Churchill Corp.
510(k) numberK872043
Submission
- Device name
- Churchill Inter-Cardiac Sucker
- Applicant
- Churchill Corp.
Langhorne, PA, US - Received
- May 27, 1987
- Decision date
- September 30, 1987
- 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 |
|---|---|---|
| K880051 | Enteral Bag/SetKNT · Traditional | 04/14/1988SE |
| K880026 | Churchill 0.22 Micron Liquid Compact Filter SetsFPB · Traditional | 04/14/1988SE |
| K880025 | Churchill 0.22 Micron Liquid Filter SetsFPB · Traditional | 04/14/1988SE |
| K880027 | Churchill 1.2 Micron Liquid Filter SetFPB · Traditional | 04/13/1988SE |
| K872585 | Churchill-CathFOZ · Traditional | 10/15/1987SE |
| K870395 | Churchill Parenteral Nutrition Bag - EvaKPE · Traditional | 10/15/1987SE |
| K872124 | Churchill Albumin IV Administration SetFPA · Traditional | 10/13/1987SE |
| K872123 | Churchill TPN Administration SetFPA · Traditional | 10/09/1987SE |
| K871084 | Nitroglycerine Pump SetFRN · Traditional | 07/16/1987SE |
| K871732 | Churchill-H Vented IV Set W/Metering ChambersFPA · Traditional | 06/15/1987SE |
Questions and answers
When was Churchill Inter-Cardiac Sucker cleared by the FDA?
Churchill Inter-Cardiac Sucker (K872043) received a 510(k) decision of Substantially Equivalent on September 30, 1987, 126 days after the submission was received.
What is the product code of K872043?
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.