The following data is part of a premarket notification filed by Intertherapy, Inc. with the FDA for Interpret(tm) Intravascular Imaging Catheter.
| Device ID | K912600 |
| 510k Number | K912600 |
| Device Name: | INTERPRET(TM) INTRAVASCULAR IMAGING CATHETER |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | INTERTHERAPY, INC. 1936 E. DEERE AVE., STE. 120 Santa Ana, CA 92705 |
| Contact | Thomas P Schroeder |
| Correspondent | Thomas P Schroeder INTERTHERAPY, INC. 1936 E. DEERE AVE., STE. 120 Santa Ana, CA 92705 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-10 |
| Decision Date | 1991-11-19 |