Hospira Latex-Free Critical Care and Advanced Sensor Catheters
FDA 510(k) K091268 · Hospira, Inc.
510(k) numberK091268
Submission
- Device name
- Hospira Latex-Free Critical Care and Advanced Sensor Catheters
- Applicant
- Hospira, Inc.
Lake Forest, IL, US - Received
- April 30, 2009
- Decision date
- September 18, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
More from Edwards Lifesciences, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K161469 | Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play ModuleFRN · Traditional | 03/28/2017SE |
| K161036 | Hospira Extension Set, Hospira Primary SetFPA · Traditional | 01/06/2017SE |
| K160492 | Hospira Sapphire SetsMRZ · Traditional | 12/06/2016SE |
| K160870 | Hospira Administration SetsFPA · Special | 06/01/2016SE |
| K143612 | LifeCare PCA Infusion SystemMEA · Traditional | 04/08/2016SE |
| K143087 | Hospira Blood SetFPA · Traditional | 03/04/2015SE |
| K143015 | Hospira Primary SetsFPA · Traditional | 02/25/2015SE |
| K141789 | Plum 360 Infusion System with Hospira Mednet, Smart Card Plug N Play Ce 3.0 Module for…FRN · Traditional | 01/16/2015SE |
| K142622 | IV AdministrationFPA · Traditional | 01/15/2015SE |
| K142974 | Extension SetsFPA · Traditional | 01/09/2015SE |
Questions and answers
When was Hospira Latex-Free Critical Care and Advanced Sensor Catheters cleared by the FDA?
Hospira Latex-Free Critical Care and Advanced Sensor Catheters (K091268) received a 510(k) decision of Substantially Equivalent on September 18, 2009, 141 days after the submission was received.
What is the product code of K091268?
The FDA product code is DQE – Catheter, Oximeter, Fiber-Optic, a Class II (moderate risk) device regulated under 21 CFR 870.1230.