The following data is part of a premarket notification filed by Ideas For Medicine, Inc. with the FDA for Pruitt Embolectomy/irrigation Catheter (modified).
| Device ID | K864062 |
| 510k Number | K864062 |
| Device Name: | PRUITT EMBOLECTOMY/IRRIGATION CATHETER (MODIFIED) |
| Classification | Catheter, Embolectomy |
| Applicant | IDEAS FOR MEDICINE, INC. P.O. BOX 270882 Tampa, FL 33688 |
| Contact | Mark R Waddell |
| Correspondent | Mark R Waddell IDEAS FOR MEDICINE, INC. P.O. BOX 270882 Tampa, FL 33688 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-20 |
| Decision Date | 1987-01-06 |