The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Viewcath 3-d Catheter Pullback.
| Device ID | K971397 |
| 510k Number | K971397 |
| Device Name: | VIEWCATH 3-D CATHETER PULLBACK |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | QUINTON, INC. 1043 KIEL COURT Sunnyvale, CA 94089 |
| Contact | Roy A Smith |
| Correspondent | Roy A Smith QUINTON, INC. 1043 KIEL COURT Sunnyvale, CA 94089 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-15 |
| Decision Date | 1997-08-25 |
| Summary: | summary |