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 | K050276 |
| 510k Number | K050276 |
| Device Name: | DIVER C.E. CATHETER |
| Classification | Aspiration Thrombectomy Catheter |
| Applicant | INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. 4600 Nathan Lane North Plymouth, MN 55442 |
| Contact | Patrice Stromberg |
| Correspondent | Patrice Stromberg INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. 4600 Nathan Lane North Plymouth, MN 55442 |
| Product Code | QEZ |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-07 |
| Decision Date | 2005-03-07 |
| Summary: | summary |