The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Imager Ii Urology Torque Catheter (c1 Tip); Imager Ii Urology Torque Catheter (c2 Tip; Imager Ii Urology Torque Catheter.
| Device ID | K102527 |
| 510k Number | K102527 |
| Device Name: | IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C2 TIP; IMAGER II UROLOGY TORQUE CATHETER |
| Classification | Catheter, Urological |
| Applicant | Boston Scientific Corporation 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Contact | Daniel Hoar |
| Correspondent | Daniel Hoar Boston Scientific Corporation 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-02 |
| Decision Date | 2010-11-05 |
| Summary: | summary |