The following data is part of a premarket notification filed by St. Jude Medical Systems Ab with the FDA for Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile Tip, Certus Agile Tip 300.
| Device ID | K140466 |
| 510k Number | K140466 |
| Device Name: | PRESSUREWIRE: AERIS AGILE TIP, AERIS AGILE TIP 300, CERTUS AGILE TIP, CERTUS AGILE TIP 300 |
| Classification | Transducer, Pressure, Catheter Tip |
| Applicant | ST. JUDE MEDICAL SYSTEMS AB PALMBLADSGATAN 10 Uppsala, SE Se-751 35 |
| Contact | Jeffrey Roberts |
| Correspondent | Anna-lisa Tiensuu ST. JUDE MEDICAL SYSTEMS AB PALMBLADSGATAN 10 Uppsala, SE Se-751 35 |
| 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 | 2014-02-24 |
| Decision Date | 2014-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734055819 | K140466 | 000 |
| 05414734055796 | K140466 | 000 |
| 05414734055772 | K140466 | 000 |
| 05414734055758 | K140466 | 000 |