The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Guidezilla Ii Guide Extension Catheter; Guidezilla Ii Long Guide Extension Catheter.
| Device ID | K163314 |
| 510k Number | K163314 |
| Device Name: | Guidezilla II Guide Extension Catheter; Guidezilla II LONG Guide Extension Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | Boston Scientific Corporation Two Scimed Place Maple Grove, MN 55311 -1566 |
| Contact | Nikki Wahlberg |
| Correspondent | Nikki Wahlberg Boston Scientific Corporation Two Scimed Place Maple Grove, MN 55311 -1566 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-23 |
| Decision Date | 2017-03-23 |
| Summary: | summary |