FDA Product Code
FDA Product Code DQE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1230
510(k) Clearances — 19 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K172423 | PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) | Edwards Lifescience, LLC | 2018-02-20 | Traditional | PDF ↗ |
| K160645 | PreSep Oligon Oximetry Catheter | Edwards Lifesciences, LLC | 2016-06-16 | Traditional | PDF ↗ |
| K140129 | PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER | Icu Medical, Inc. | 2014-07-02 | Traditional | PDF ↗ |
| K110167 | PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN) | Edwards Lifesciences, LLC | 2011-02-18 | Special | PDF ↗ |
| K091268 | HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS | Hospira, Inc. | 2009-09-18 | Special | PDF ↗ |
| K062999 | OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN | Hospira, Inc. | 2006-11-03 | Special | PDF ↗ |
| K061585 | OPTICATH CENTRAL VENOUS OXIMETRY CATHETER | Hospira, Inc. | 2006-10-05 | Traditional | PDF ↗ |
| K061450 | HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS | Hospira, Inc. | 2006-08-04 | Traditional | PDF ↗ |
| K061159 | OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN | Hospira, Inc. | 2006-06-26 | Traditional | PDF ↗ |
| K060093 | PRESEP OLIGON OXIMETRY CATHETERS | Edwards Lifesciences, LLC | 2006-04-28 | Traditional | PDF ↗ |
| K053609 | PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR | Edwards Lifesciences, LLC | 2006-02-28 | Traditional | PDF ↗ |
| K926450 | EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH | Baxter Healthcare Corp | 1993-02-22 | Traditional | PDF ↗ |
| K915073 | MARQUETTE SV O2 MODULE | Marquette Electronics, Inc. | 1992-12-29 | Traditional | PDF ↗ |
| K905458 | SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER | Baxter Healthcare Corp | 1991-02-07 | Traditional | PDF ↗ |
| K901736 | OXIMETRY PROBE CATHETERS | Baxter Healthcare Corp | 1990-09-11 | Traditional | PDF ↗ |
| K864745 | POET OXIMETER | Criticare Systems, Inc. | 1987-06-02 | Traditional | PDF ↗ |
| K820674 | OPTICATH | Oximetrix, Inc. | 1982-03-25 | Traditional | PDF ↗ |
| K781134 | CATHETER, THERMAL DILUTION FIBEROPTIC | Oximetrix, Inc. | 1978-08-17 | Traditional | PDF ↗ |
| K760234 | OXIMETER, IN VIVO CATHETER | Oximetrix, Inc. | 1976-08-23 | Traditional | PDF ↗ |
Product code DQE · Class II · Cardiovascular. Data: openFDA.