The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Pressurewire Certus, Certus 300, Aeris, Aeris 300, And Receiver.
| Device ID | K113584 |
| 510k Number | K113584 |
| Device Name: | PRESSUREWIRE CERTUS, CERTUS 300, AERIS, AERIS 300, AND RECEIVER |
| Classification | Transducer, Pressure, Catheter Tip |
| Applicant | ST. JUDE MEDICAL 4 ROBBINS ROAD Westford, MA 01886 |
| Contact | Bryan Cowell |
| Correspondent | Bryan Cowell ST. JUDE MEDICAL 4 ROBBINS ROAD Westford, MA 01886 |
| 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 | 2011-12-05 |
| Decision Date | 2012-03-02 |
| Summary: | summary |