The following data is part of a premarket notification filed by Biosense Webster, Inc. with the FDA for Soundstar Eco Diagnostic Ultrasound Catheter.
| Device ID | K112050 |
| 510k Number | K112050 |
| Device Name: | SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | BIOSENSE WEBSTER, INC. 3333 DIAMOND CANYON RD Diamond Bar, CA 91765 |
| Contact | Marina Guevrekian |
| Correspondent | Marina Guevrekian 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 | 2011-07-18 |
| Decision Date | 2011-11-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10846835008845 | K112050 | 000 |
| 10846835008838 | K112050 | 000 |