DQE — Catheter, Oximeter, Fiber-Optic Class II
FDA product code DQE covers "Catheter, Oximeter, Fiber-Optic", a Class II medical device regulated under 21 CFR 870.1230. Submissions are reviewed by the Cardiovascular panel. At least 19 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DQE
- Device Class
- Class II
- Regulation Number
- 870.1230
- Submission Type
- 510(k)
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K172423 | Edwards Lifescience | PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry… | Feb 20, 2018 |
| K160645 | Edwards Lifesciences | PreSep Oligon Oximetry Catheter | Jun 16, 2016 |
| K140129 | Icu Medical | PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY… | Jul 2, 2014 |
| K110167 | Edwards Lifesciences | PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN) | Feb 18, 2011 |
| K091268 | Hospira | HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS | Sep 18, 2009 |
| K062999 | Hospira | OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN | Nov 3, 2006 |
| K061585 | Hospira | OPTICATH CENTRAL VENOUS OXIMETRY CATHETER | Oct 5, 2006 |
| K061450 | Hospira | HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE… | Aug 4, 2006 |
| K061159 | Hospira | OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN | Jun 26, 2006 |
| K060093 | Edwards Lifesciences | PRESEP OLIGON OXIMETRY CATHETERS | Apr 28, 2006 |
| K053609 | Edwards Lifesciences | PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC… | Feb 28, 2006 |
| K926450 | Baxter Healthcare | EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH | Feb 22, 1993 |
| K915073 | Marquette Electronics | MARQUETTE SV O2 MODULE | Dec 29, 1992 |
| K905458 | Baxter Healthcare | SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER | Feb 7, 1991 |
| K901736 | Baxter Healthcare | OXIMETRY PROBE CATHETERS | Sep 11, 1990 |
| K864745 | Criticare Systems | POET OXIMETER | Jun 2, 1987 |
| K820674 | Oximetrix | OPTICATH | Mar 25, 1982 |
| K781134 | Oximetrix | CATHETER, THERMAL DILUTION FIBEROPTIC | Aug 17, 1978 |
| K760234 | Oximetrix | OXIMETER, IN VIVO CATHETER | Aug 23, 1976 |