Product code DQE
- Device name
- Catheter, Oximeter, Fiber-Optic
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1230
- Review panel
- CV
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K172423 | PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) | Edwards Lifescience, LLC | 2018-02-20 |
| K160645 | PreSep Oligon Oximetry Catheter | Edwards Lifesciences, LLC | 2016-06-16 |
| K140129 | PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER | Icu Medical, Inc. | 2014-07-02 |
| K110167 | PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN) | Edwards Lifesciences, LLC | 2011-02-18 |
| K091268 | HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS | Hospira, Inc. | 2009-09-18 |
| K062999 | OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN | Hospira, Inc. | 2006-11-03 |
| K061585 | OPTICATH CENTRAL VENOUS OXIMETRY CATHETER | Hospira, Inc. | 2006-10-05 |
| K061450 | HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS | Hospira, Inc. | 2006-08-04 |
| K061159 | OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN | Hospira, Inc. | 2006-06-26 |
| K060093 | PRESEP OLIGON OXIMETRY CATHETERS | Edwards Lifesciences, LLC | 2006-04-28 |
| K053609 | PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR | Edwards Lifesciences, LLC | 2006-02-28 |
| K926450 | EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH | Baxter Healthcare Corp | 1993-02-22 |
| K915073 | MARQUETTE SV O2 MODULE | Marquette Electronics, Inc. | 1992-12-29 |
| K905458 | SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER | Baxter Healthcare Corp | 1991-02-07 |
| K901736 | OXIMETRY PROBE CATHETERS | Baxter Healthcare Corp | 1990-09-11 |
| K864745 | POET OXIMETER | Criticare Systems, Inc. | 1987-06-02 |
| K820674 | OPTICATH | Oximetrix, Inc. | 1982-03-25 |
| K781134 | CATHETER, THERMAL DILUTION FIBEROPTIC | Oximetrix, Inc. | 1978-08-17 |
| K760234 | OXIMETER, IN VIVO CATHETER | Oximetrix, Inc. | 1976-08-23 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00690103000382 | SWAN-GANZ TRUE SIZE | Edwards Lifesciences LLC | 2026-03-16 |
| 00690103000412 | SWAN-GANZ | Edwards Lifesciences LLC | 2026-01-30 |
| 00690103003109 | SWAN-GANZ | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103181449 | VIGILEO | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103176810 | PRESEP | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103165418 | FLOTRAC, VIGILEO | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103161236 | SWAN-GANZ | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103153132 | SWAN-GANZ CONTROLCATH | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103151961 | SWAN-GANZ PACEPORT | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103151756 | SWAN-GANZ VIP+ | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103146998 | SWAN-GANZ CCOMBO V | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103146554 | SWAN-GANZ CCOMBO V | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103018295 | SWAN-GANZ TRUE SIZE | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103017823 | SWAN-GANZ HI-SHORE TRUE SIZE | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103017243 | SWAN-GANZ CONTROLCATH TRUE SIZE | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103017236 | SWAN-GANZ TRUE SIZE | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103005134 | SWAN-GANZ CONTROLCATH TRUE SIZE | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103000245 | SWAN-GANZ TRUE SIZE | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103003031 | SWAN-GANZ VIP | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103002881 | SWAN-GANZ CCOMBO | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103002850 | SWAN-GANZ CCOMBO | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103000566 | SWAN-GANZ TRUE SIZE | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103000542 | SWAN-GANZ CARDIOCATH TRUE SIZE | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103000504 | SWAN-GANZ HI-SHORE TRUE SIZE | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103000474 | SWAN-GANZ | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103000467 | SWAN-GANZ TRUE SIZE | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103000405 | SWAN-GANZ | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103000375 | SWAN-GANZ TRUE SIZE | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103000313 | SWAN-GANZ TRUE SIZE | Edwards Lifesciences LLC | 2016-09-03 |
| 00690103000269 | SWAN-GANZ | Edwards Lifesciences LLC | 2016-09-03 |