The following data is part of a premarket notification filed by Medical Dynamics, Inc. with the FDA for Optical Catheter(tm) Introducer Sets.
| Device ID | K895041 |
| 510k Number | K895041 |
| Device Name: | OPTICAL CATHETER(TM) INTRODUCER SETS |
| Classification | Accessories, Catheter |
| Applicant | MEDICAL DYNAMICS, INC. 99 INVERNESS DR., EAST Englewood, CO 80112 |
| Contact | Jo Brehm |
| Correspondent | Jo Brehm MEDICAL DYNAMICS, INC. 99 INVERNESS DR., EAST Englewood, CO 80112 |
| Product Code | KGZ |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-09 |
| Decision Date | 1989-10-16 |