The following data is part of a premarket notification filed by Health Care Innovations, Inc. with the FDA for Hci General Purpose Catheter Stylet.
| Device ID | K870014 |
| 510k Number | K870014 |
| Device Name: | HCI GENERAL PURPOSE CATHETER STYLET |
| Classification | Accessories, Catheter |
| Applicant | HEALTH CARE INNOVATIONS, INC. 609 DUNDEE RD. Glencoe, IL 60022 |
| Contact | Craig S Steadman |
| Correspondent | Craig S Steadman HEALTH CARE INNOVATIONS, INC. 609 DUNDEE RD. Glencoe, IL 60022 |
| Product Code | KGZ |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-02 |
| Decision Date | 1987-02-06 |