The following data is part of a premarket notification filed by Endosonics Corp. with the FDA for Precept-gt(tm) Microsensor Pressure Monitor Cath..
| Device ID | K894747 |
| 510k Number | K894747 |
| Device Name: | PRECEPT-GT(TM) MICROSENSOR PRESSURE MONITOR CATH. |
| Classification | Transducer, Pressure, Catheter Tip |
| Applicant | ENDOSONICS CORP. 3078-B PROSPECT PARK DR. Rancho Cordova, CA 95670 |
| Contact | Adam D Savakus |
| Correspondent | Adam D Savakus ENDOSONICS CORP. 3078-B PROSPECT PARK DR. Rancho Cordova, CA 95670 |
| Product Code | DXO |
| CFR Regulation Number | 870.2870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-26 |
| Decision Date | 1989-10-12 |