The following data is part of a premarket notification filed by Cardiovascular Imaging Systems, Inc. with the FDA for Bsc, Sonicath Ultra Imaging Catheter 3.2f/20mhz(37410/456221 & Bsc, Sonicath Ultra Imaging Catheter 2.9f/20mhz/37411/.
| Device ID | K970049 |
| 510k Number | K970049 |
| Device Name: | BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/ |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | CARDIOVASCULAR IMAGING SYSTEMS, INC. 1327 ORLEANS DR. Sunnyvale, CA 94089 -1136 |
| Contact | Steve Jwanouskos |
| Correspondent | Steve Jwanouskos CARDIOVASCULAR IMAGING SYSTEMS, INC. 1327 ORLEANS DR. Sunnyvale, CA 94089 -1136 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-06 |
| Decision Date | 1997-06-20 |
| Summary: | summary |