Presep Oligon Oximetry Catheters
FDA 510(k) K060093 · Edwards Lifesciences, LLC
510(k) numberK060093
Submission
- Device name
- Presep Oligon Oximetry Catheters
- Applicant
- Edwards Lifesciences, LLC
Irvine, CA, US - Received
- January 12, 2006
- Decision date
- April 28, 2006
- 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 |
|---|---|---|---|
| K172423 | PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central…DQE · Traditional | Edwards Lifescience, LLC | 02/20/2018SE |
| 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 |
| K053609 | Presep and Pediasat Oximetry Catheters and Vigileo Arterial Pressure Cardiac…DQE · Traditional | Edwards Lifesciences, LLC | 02/28/2006SE |
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Questions and answers
When was Presep Oligon Oximetry Catheters cleared by the FDA?
Presep Oligon Oximetry Catheters (K060093) received a 510(k) decision of Substantially Equivalent on April 28, 2006, 106 days after the submission was received.
What is the product code of K060093?
The FDA product code is DQE – Catheter, Oximeter, Fiber-Optic, a Class II (moderate risk) device regulated under 21 CFR 870.1230.