Pressurewire; Certus, Certus 300, Aeris, Aeris 300
FDA 510(k) K131452 · St. Jude Medical Systems AB
510(k) numberK131452
Submission
- Device name
- Pressurewire; Certus, Certus 300, Aeris, Aeris 300
- Applicant
- St. Jude Medical Systems AB
Westford, MA, US - Received
- May 20, 2013
- Decision date
- September 5, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXO – Transducer, Pressure, Catheter Tip
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2870
- Specialty
- Cardiovascular
Other 510(k)s with product code DXO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251367 | OptoMonitor 3DXO · Traditional | Opsens, Inc. | 01/16/2026SE |
| K241418 | OptoMonitor 3DXO · Traditional | Opsens, Inc. | 02/12/2025SE |
| K233904 | ACIST RXi System (016616); ACIST Navvus II Catheter (016675_DXO · Traditional | Acist Medical Systems, Inc. | 07/17/2024SE |
| K222216 | TruWave Disposable Pressure TransducerDXO · Traditional | Edwards Lifesciences, LLC | 12/22/2022SE |
| K202943 | OptoMonitor 3DXO · Traditional | Opsens, Inc. | 11/24/2020SE |
| K193620 | OptoMonitor 3DXO · Traditional | Opsens, Inc. | 06/18/2020SE |
| K193279 | Comet II Pressure GuidewireDXO · Special | Boston Scientific Corporation | 12/23/2019SE |
| K192340 | OptoMonitorDXO · Traditional | Opsens, Inc. | 12/12/2019SE |
| K190852 | Zurich Pressure Guidewire System Model 100DXO · Traditional | Zurich Medical, Inc. | 08/14/2019SE |
| K183413 | TruWave Disposable Pressure TransducerDXO · Traditional | Edwards Lifeciences, LLC | 05/01/2019SE |
More from Edwards Lifeciences, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K140466 | Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile Tip, Certus Agile Tip 300DXO · Traditional | 11/13/2014SE |
| K133587 | Pressurewire Aeris Agile Tip; Pressurewire Aeris Agile Tip 300DRG · Special | 12/20/2013SE |
| K111854 | Ao Usb Receiver, Wi-Box, Wi-Box Psu Kit, Wi-Box Xpress Cable, PW Usb ReceiverDRG · Traditional | 10/21/2011SE |
| K110193 | Femostop Plys, Femostop HD, Femostop Compression Arch; Femostop II Plus Set; Femostop II…DXC · Special | 02/24/2011SE |
Questions and answers
When was Pressurewire; Certus, Certus 300, Aeris, Aeris 300 cleared by the FDA?
Pressurewire; Certus, Certus 300, Aeris, Aeris 300 (K131452) received a 510(k) decision of Substantially Equivalent on September 5, 2013, 108 days after the submission was received.
What is the product code of K131452?
The FDA product code is DXO – Transducer, Pressure, Catheter Tip, a Class II (moderate risk) device regulated under 21 CFR 870.2870.