OXIMETER, IN VIVO CATHETER
FDA 510(k) clearance K760234 · decided 1976-08-23
Clearance details
- K-number
- K760234
- Device name
- OXIMETER, IN VIVO CATHETER
- Applicant
- Oximetrix, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1976-07-15
- Decision date
- 1976-08-23
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- DQE
- Device class
- 2
- Regulation number
- 870.1230
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) (K172423) | Edwards Lifescience, LLC | 2018-02-20 |
| PreSep Oligon Oximetry Catheter (K160645) | Edwards Lifesciences, LLC | 2016-06-16 |
| PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER (K140129) | Icu Medical, Inc. | 2014-07-02 |
| PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN) (K110167) | Edwards Lifesciences, LLC | 2011-02-18 |
| HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS (K091268) | Hospira, Inc. | 2009-09-18 |
| OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN (K062999) | Hospira, Inc. | 2006-11-03 |
| OPTICATH CENTRAL VENOUS OXIMETRY CATHETER (K061585) | Hospira, Inc. | 2006-10-05 |
| HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS (K061450) | Hospira, Inc. | 2006-08-04 |
| OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN (K061159) | Hospira, Inc. | 2006-06-26 |
| PRESEP OLIGON OXIMETRY CATHETERS (K060093) | Edwards Lifesciences, LLC | 2006-04-28 |
| PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR (K053609) | Edwards Lifesciences, LLC | 2006-02-28 |
| EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH (K926450) | Baxter Healthcare Corp | 1993-02-22 |
Recalls involving this device
No recalls on record reference this clearance.