Pressurewire Certus, Certus 300, Aeris, Aeris 300, and Receiver
FDA 510(k) K113584 · St Jude Medical
510(k) numberK113584
Submission
- Device name
- Pressurewire Certus, Certus 300, Aeris, Aeris 300, and Receiver
- Applicant
- St Jude Medical
Westford, MA, US - Received
- December 5, 2011
- Decision date
- March 2, 2012
- 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 |
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| K172393 | Advisor HD Grid Mapping Catheter, Sensor EnabledMTD · Traditional | 04/23/2018SE |
| K173232 | myMerlin(TM) Mobile Application Model APP1001MXC · Special | 11/02/2017SE |
| K163407 | Confirm Rx Insertable Cardiac Monitor (ICM) SystemMXC · Traditional | 09/29/2017SE |
| K162643 | MediGuide Technology SystemDQK · Traditional | 12/13/2016SE |
| K160335 | Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12…DRF · Traditional | 12/13/2016SE |
| K160218 | AutoMark ModuleDQK · Traditional | 12/13/2016SE |
| K160210 | EnSite Precision Cardiac Mapping System v2.0DQK · Traditional | 12/13/2016SE |
| K161873 | Pacel Flow Directed Pacing CatheterLDF · Traditional | 11/22/2016SE |
Questions and answers
When was Pressurewire Certus, Certus 300, Aeris, Aeris 300, and Receiver cleared by the FDA?
Pressurewire Certus, Certus 300, Aeris, Aeris 300, and Receiver (K113584) received a 510(k) decision of Substantially Equivalent on March 2, 2012, 88 days after the submission was received.
What is the product code of K113584?
The FDA product code is DXO – Transducer, Pressure, Catheter Tip, a Class II (moderate risk) device regulated under 21 CFR 870.2870.