PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)
FDA 510(k) K172423 · Edwards Lifescience, LLC
510(k) numberK172423
Submission
- Device name
- PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)
- Applicant
- Edwards Lifescience, LLC
Irvine, CA, US - Received
- August 10, 2017
- Decision date
- February 20, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQE – Catheter, Oximeter, Fiber-Optic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1230
- Specialty
- Cardiovascular
Other 510(k)s with product code DQE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K160645 | PreSep Oligon Oximetry CatheterDQE · Traditional | Edwards Lifesciences, LLC | 06/16/2016SE |
| K140129 | Piccox Peripherally Inserted Pressure Injectable, Central Venous Oximetry CatheterDQE · Traditional | Icu Medical, Inc. | 07/02/2014SE |
| K110167 | Presep Oligon Oximetry Catheters (16 CM, W/Heparin), (20CM, W/Heparin)DQE · Special | Edwards Lifesciences, LLC | 02/18/2011SE |
| K091268 | Hospira Latex-Free Critical Care and Advanced Sensor CathetersDQE · Special | Hospira, Inc. | 09/18/2009SE |
| K062999 | Opticath Central Venous Oximetry Probe with Seal with HeparinDQE · Special | Hospira, Inc. | 11/03/2006SE |
| K061585 | Opticath Central Venous Oximetry CatheterDQE · Traditional | Hospira, Inc. | 10/05/2006SE |
| K061450 | Hospira Latex-Free Advanced Sensor Catheters; Hospira Latex-Free Critical Care CathetersDQE · Traditional | Hospira, Inc. | 08/04/2006SE |
| K061159 | Opticath Central Venous Oximetry Probe with Fluidic Seal With/Without HeparinDQE · Traditional | Hospira, Inc. | 06/26/2006SE |
| K060093 | Presep Oligon Oximetry CathetersDQE · Traditional | Edwards Lifesciences, LLC | 04/28/2006SE |
| K053609 | Presep and Pediasat Oximetry Catheters and Vigileo Arterial Pressure Cardiac…DQE · Traditional | Edwards Lifesciences, LLC | 02/28/2006SE |
Questions and answers
When was PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) cleared by the FDA?
PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) (K172423) received a 510(k) decision of Substantially Equivalent on February 20, 2018, 194 days after the submission was received.
What is the product code of K172423?
The FDA product code is DQE – Catheter, Oximeter, Fiber-Optic, a Class II (moderate risk) device regulated under 21 CFR 870.1230.