The following data is part of a premarket notification filed by Boston Scientific, Target with the FDA for Guider Softip Guiding Catheter Xf 5f.
| Device ID | K010853 |
| 510k Number | K010853 |
| Device Name: | GUIDER SOFTIP GUIDING CATHETER XF 5F |
| Classification | Catheter, Percutaneous |
| Applicant | BOSTON SCIENTIFIC, TARGET 47900 BAYSIDE PKWY. Fremont, CA 94538 |
| Contact | Roxane K Baxter |
| Correspondent | Roxane K Baxter BOSTON SCIENTIFIC, TARGET 47900 BAYSIDE PKWY. Fremont, CA 94538 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-21 |
| Decision Date | 2001-04-18 |