510(k) K172423
- Device
- PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)
- Applicant
- Edwards Lifescience LLC
- 510(k) number
- K172423
- Product code
- DQE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-02-20
- Date received
- 2017-08-10
- Regulation
- 870.1230
- Classification name
- Catheter, Oximeter, Fiber-optic
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Bedalin T. Lugo Rodriguez
- Address
- One Edwards Way Irvine CA US 92614 92614
FDA Registration Numbers#
- 1721676
- 9617594
- 9615817
- 3032916632
- 3005783425
- 1018233
- 3013500228
- 2025816
- 3037724692
- 3013596024
- 1314417
- 3006082230
- 1720929
- 3013319212
- 3008483389
- 3003615065
- 3004832480
- 3010838917
- 1713468
- 2648045
- 2133641
Source Documents#
Other 510(k) Records For Product Code DQE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
Legacy Summary#
summary
FDA Review#
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