510(k) K222117
K222117 is an FDA 510(k) premarket notification submitted by Edwards Lifesiences, LLC for the device "Swang-Ganz IQ pulmonary artery catheter". The FDA issued a decision of Substantially Equivalent on December 9, 2022. The device falls under product code DYG (Catheter, Flow Directed), a Class II device regulated under 21 CFR 870.1240. Edwards Lifesiences, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 2022
- Date Received
- July 18, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Flow Directed
- Device Class
- Class II
- Regulation Number
- 870.1240
- Review Panel
- CV
- Submission Type