510(k) K163693
K163693 is an FDA 510(k) premarket notification submitted by Edwards Lifesciences, LLC for the device "IntraClude Intra-Aortic Occlusion Device". The FDA issued a decision of Substantially Equivalent on Jan 26, 2017. The device falls under product code DXC (Clamp, Vascular), a Class II device regulated under 21 CFR 870.4450. Edwards Lifesciences, LLC has 157 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 26, 2017
- Date Received
- Dec 28, 2016
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Vascular
- Device Class
- Class II
- Regulation Number
- 870.4450
- Review Panel
- CV
- Submission Type
- 510(k)