The following data is part of a premarket notification filed by Ideas For Medicine, Inc. with the FDA for Change Of Catheter Body Material (radio-opaque Ny).
| Device ID | K872485 |
| 510k Number | K872485 |
| Device Name: | CHANGE OF CATHETER BODY MATERIAL (RADIO-OPAQUE NY) |
| Classification | Catheter, Embolectomy |
| Applicant | IDEAS FOR MEDICINE, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
| Contact | Mark R Waddell |
| Correspondent | Mark R Waddell IDEAS FOR MEDICINE, INC. 12167 49TH ST. NORTH P.O. BOX 17327 Clearwater, FL 34622 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-22 |
| Decision Date | 1987-08-12 |