The following data is part of a premarket notification filed by Invatec Innovative Technologies, S.r.l. with the FDA for Diver C.e. Catheter.
| Device ID | K051917 |
| 510k Number | K051917 |
| Device Name: | DIVER C.E. CATHETER |
| Classification | Catheter, Embolectomy |
| Applicant | INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. 4600 Nathan Lane North Plymouth, MN 55442 |
| Contact | Stephanie K Isgrigg Robinson |
| Correspondent | Stephanie K Isgrigg Robinson INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. 4600 Nathan Lane North Plymouth, MN 55442 |
| Product Code | DXE |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-15 |
| Decision Date | 2005-08-08 |
| Summary: | summary |