510(k) K160645
K160645 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "PreSep Oligon Oximetry Catheter". The FDA issued a decision of Substantially Equivalent on Jun 16, 2016. The device falls under product code DQE (Catheter, Oximeter, Fiber-Optic), a Class II device regulated under 21 CFR 870.1230. Edwards Lifesciences, LLC has 157 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 16, 2016
- Date Received
- Mar 7, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Oximeter, Fiber-Optic
- Device Class
- Class II
- Regulation Number
- 870.1230
- Review Panel
- CV
- Submission Type
- 510(k)