The following data is part of a premarket notification filed by Sentron, Inc. with the FDA for Modifications To Series Of Cardiac Catheters.
| Device ID | K913042 |
| 510k Number | K913042 |
| Device Name: | MODIFICATIONS TO SERIES OF CARDIAC CATHETERS |
| Classification | Transducer, Pressure, Catheter Tip |
| Applicant | SENTRON, INC. 34008 9TH AVENUE S. Federal Way, WA 98003 |
| Contact | John Brekke |
| Correspondent | John Brekke SENTRON, INC. 34008 9TH AVENUE S. Federal Way, WA 98003 |
| Product Code | DXO |
| CFR Regulation Number | 870.2870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-25 |
| Decision Date | 1992-10-21 |