The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Roll-x Guidewire.
| Device ID | K100710 |
| 510k Number | K100710 |
| Device Name: | ROLL-X GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | ST. JUDE MEDICAL 14901 DEVEAU PL. Minnetonka, MN 55345 -2126 |
| Contact | Jennifer Zwiefelhofer |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-03-12 |
| Decision Date | 2010-04-28 |
| Summary: | summary |