Pressurewire Certus, Models 12006 and 12306
FDA 510(k) K062769 · Radi Medical Systems AB
510(k) numberK062769
Submission
- Device name
- Pressurewire Certus, Models 12006 and 12306
- Applicant
- Radi Medical Systems AB
Uppsala, SE - Received
- September 15, 2006
- Decision date
- December 4, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K123984 | Quantien Measurement SystemDQK · Special | 03/28/2013SE |
| K092105 | Radianalyzer XpressDQK · Traditional | 10/09/2009SE |
| K080813 | Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverDXO · Traditional | 07/01/2008SE |
| K080206 | Modification to Femostop Femoral Compression SystemDXC · Special | 02/26/2008SE |
| K042628 | Modification to: Radianalyzer, Model 12711DQK · Traditional | 01/19/2005SE |
| K033291 | Topseal Hemostatic Dressing, Model 11150QSY · Traditional | 03/17/2004SE |
| K031662 | Pressure Wire Sensor, Models 12004/12304DXO · Special | 06/06/2003SE |
| K024107 | Femostop Femoral Compression SystemDXC · Special | 12/24/2002SE |
| K022188 | Radianalyzer, Model 12710DQK · Traditional | 10/03/2002SE |
| K022187 | Pressure Wire Sensor, Models 12003/12303, 12004/12304DXO · Traditional | 09/24/2002SE |
Questions and answers
When was Pressurewire Certus, Models 12006 and 12306 cleared by the FDA?
Pressurewire Certus, Models 12006 and 12306 (K062769) received a 510(k) decision of Substantially Equivalent on December 4, 2006, 80 days after the submission was received.
What is the product code of K062769?
The FDA product code is DXO – Transducer, Pressure, Catheter Tip, a Class II (moderate risk) device regulated under 21 CFR 870.2870.