The following data is part of a premarket notification filed by Churchill Corp. with the FDA for Churchill Inter-cardiac Sucker.
| Device ID | K872043 |
| 510k Number | K872043 |
| Device Name: | CHURCHILL INTER-CARDIAC SUCKER |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | CHURCHILL CORP. ONE SUMMIT SQUARE ROUTE 413 & DOUBLEWOODS ROAD Langhorne, PA 19047 |
| Contact | David W Evans |
| Correspondent | David W Evans CHURCHILL CORP. ONE SUMMIT SQUARE ROUTE 413 & DOUBLEWOODS ROAD Langhorne, PA 19047 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-27 |
| Decision Date | 1987-09-30 |