Cardiovascular Imaging Systems, Inc. · Class II · Cleared Jun 20, 1997
| K-number | K970049 |
| Device name | BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/ |
| Applicant | Cardiovascular Imaging Systems, Inc. |
| Product code | ITX |
| Device class | Class II |
| Decision date | Jun 20, 1997 |
| Decision | Substantially Equivalent |
| Regulation | 892.1570 |
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