The following data is part of a premarket notification filed by Radi Medical Systems Ab with the FDA for Pressure Wire Sensor .014, Pressure Wire Interface 10, Pressure Wire Monitor Cable.
| Device ID | K972793 |
| 510k Number | K972793 |
| Device Name: | PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE |
| Classification | Wire, Guide, Catheter |
| Applicant | RADI MEDICAL SYSTEMS AB PALMBLADSGATAN 10 Uppsala, SE S-754 50 |
| Contact | Mats Granlund |
| Correspondent | Mats Granlund RADI MEDICAL SYSTEMS AB PALMBLADSGATAN 10 Uppsala, SE S-754 50 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-28 |
| Decision Date | 1998-04-24 |
| Summary: | summary |