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 |