PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)
FDA 510(k) clearance K172423 · decided 2018-02-20
Clearance details
- K-number
- K172423
- Device name
- PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)
- Applicant
- Edwards Lifescience, LLC
- Decision
- Substantially Equivalent
- Date received
- 2017-08-10
- Decision date
- 2018-02-20
- Days to decision
- 194 days
- Clearance type
- Traditional
- Product code
- DQE
- Device class
- 2
- Regulation number
- 870.1230
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)006901 recall (Z-2007-2020) | Edwards Lifesciences, LLC | 2020-07-10 |