The following data is part of a premarket notification filed by Shiley, Inc. with the FDA for Stockert-shiley Handheld Remote Control Intracardi.
| Device ID | K844138 |
| 510k Number | K844138 |
| Device Name: | STOCKERT-SHILEY HANDHELD REMOTE CONTROL INTRACARDI |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Contact | Robert Curtis |
| Correspondent | Robert Curtis SHILEY, INC. 17600 GILLETTE AVE. P.O. BOX 19503 Irvine, CA 92714 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-23 |
| Decision Date | 1984-12-27 |