The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Soundstar 3d Ultrasound Catheter Model M-5723-12.
| Device ID | K101138 |
| 510k Number | K101138 |
| Device Name: | SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12 |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Contact | Melissa C Schultz, Rac, Mms |
| Correspondent | Melissa C Schultz, Rac, Mms BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD. Diamond Bar, CA 91765 |
| Product Code | OBJ |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-22 |
| Decision Date | 2010-06-22 |
| Summary: | summary |