The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Imager Ii Urology Torque Catheter, Model 40030x1, 40040x1, And 40050x1.
| Device ID | K011965 |
| 510k Number | K011965 |
| Device Name: | IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1 |
| Classification | Catheter, Urological |
| Applicant | BOSTON SCIENTIFIC CORP. One Boston Scientific Place Natick, MA 01760 |
| Contact | Robert J Michalik |
| Correspondent | Robert J Michalik BOSTON SCIENTIFIC CORP. One Boston Scientific Place Natick, MA 01760 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-25 |
| Decision Date | 2001-07-13 |
| Summary: | summary |