The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Sonicath(tm) 9f, 12 Mhz.
| Device ID | K902245 |
| 510k Number | K902245 |
| Device Name: | SONICATH(TM) 9F, 12 MHZ |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | BOSTON SCIENTIFIC CORP. 480 PLEASANT ST. P.O. BOX 7407 Watertown, MA 02272 |
| Contact | Jeanne M Lesniak |
| Correspondent | Jeanne M Lesniak BOSTON SCIENTIFIC CORP. 480 PLEASANT ST. P.O. BOX 7407 Watertown, MA 02272 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-18 |
| Decision Date | 1990-10-09 |