The following data is part of a premarket notification filed by Boston Scientific with the FDA for Judo 1 Guidewire, Judo 3 Guidewire, Judo 6 Guidewire.
| Device ID | K180795 |
| 510k Number | K180795 |
| Device Name: | JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire |
| Classification | Wire, Guide, Catheter |
| Applicant | Boston Scientific Three Scimed Place Maple Grove, MN 55311 -1566 |
| Contact | Nikki M. Ibis |
| Correspondent | Nikki M. Ibis Boston Scientific Three Scimed Place Maple Grove, MN 55311 -1566 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-27 |
| Decision Date | 2018-04-12 |
| Summary: | summary |