The following data is part of a premarket notification filed by Cardiovascular Imaging Systems, Inc. with the FDA for Cvis Insight Imaging Catheters.
| Device ID | K911414 |
| 510k Number | K911414 |
| Device Name: | CVIS INSIGHT IMAGING CATHETERS |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | CARDIOVASCULAR IMAGING SYSTEMS, INC. 595 NORTH PASTORIA AVE. Sunnyvale, CA 94085 |
| Contact | Russell W Felkey |
| Correspondent | Russell W Felkey CARDIOVASCULAR IMAGING SYSTEMS, INC. 595 NORTH PASTORIA AVE. Sunnyvale, CA 94085 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-01 |
| Decision Date | 1991-09-11 |