The following data is part of a premarket notification filed by Invatec Innovative Technologies, S.r.l. with the FDA for Skipper And Skipper Race Guidewire.
| Device ID | K050756 |
| 510k Number | K050756 |
| Device Name: | SKIPPER AND SKIPPER RACE GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. 4600 Nathan Lane North Plymouth, MN 55442 |
| Contact | Melissa Sommerfeld |
| Correspondent | Melissa Sommerfeld INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. 4600 Nathan Lane North Plymouth, MN 55442 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-23 |
| Decision Date | 2005-05-05 |
| Summary: | summary |