The following data is part of a premarket notification filed by St. Jude Medical Inc. with the FDA for Pressurewire X Guidewire.
| Device ID | K161171 |
| 510k Number | K161171 |
| Device Name: | PressureWire X Guidewire |
| Classification | Transducer, Pressure, Catheter Tip |
| Applicant | ST. JUDE MEDICAL INC. 5050 NATHAN LANE NORTH Plymouth, MN 55442 |
| Contact | Huda Yusuf |
| Correspondent | Huda Yusuf ST. JUDE MEDICAL INC. 5050 NATHAN LANE NORTH Plymouth, MN 55442 |
| Product Code | DXO |
| Subsequent Product Code | DQX |
| Subsequent Product Code | DRG |
| CFR Regulation Number | 870.2870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-26 |
| Decision Date | 2016-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15415067025743 | K161171 | 000 |
| 15415067025736 | K161171 | 000 |
| 05415067025722 | K161171 | 000 |
| 15415067025712 | K161171 | 000 |