The following data is part of a premarket notification filed by Biosense Webster with the FDA for Soundstar Eco 8f Gultrasound Catheter, Soundstar Eco 8f Ultrasound Catheter.
| Device ID | K140318 |
| 510k Number | K140318 |
| Device Name: | SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER |
| Classification | Catheter, Ultrasound, Intravascular |
| Applicant | BIOSENSE WEBSTER 3333 DIAMOND CANYON RD. Baldwin Bar, CA 91765 |
| Contact | Marina Guevrekian |
| Correspondent | Marina Guevrekian BIOSENSE WEBSTER 3333 DIAMOND CANYON RD. Baldwin 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 | 2014-02-10 |
| Decision Date | 2014-03-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10846835008869 | K140318 | 000 |
| 10846835008852 | K140318 | 000 |