The following data is part of a premarket notification filed by St. Jude Medical Systems Ab with the FDA for Pressurewire Aeris Agile Tip; Pressurewire Aeris Agile Tip 300.
| Device ID | K133587 |
| 510k Number | K133587 |
| Device Name: | PRESSUREWIRE AERIS AGILE TIP; PRESSUREWIRE AERIS AGILE TIP 300 |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | ST. JUDE MEDICAL SYSTEMS AB 4 ROBBINS RD. Westford, MA 01886 |
| Contact | Erdulfo De Peralta |
| Correspondent | Erdulfo De Peralta ST. JUDE MEDICAL SYSTEMS AB 4 ROBBINS RD. Westford, MA 01886 |
| Product Code | DRG |
| Subsequent Product Code | DQX |
| Subsequent Product Code | DXO |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-21 |
| Decision Date | 2013-12-20 |
| Summary: | summary |