510(k) K211679
K211679 is an FDA 510(k) premarket notification submitted by Xcardia Innovation , Ltd. for the device "Xtractor device". The FDA issued a decision of Substantially Equivalent on February 17, 2022. The device falls under product code DRE (Dilator, Vessel, For Percutaneous Catheterization), a Class II device regulated under 21 CFR 870.1310.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 2022
- Date Received
- June 1, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Vessel, For Percutaneous Catheterization
- Device Class
- Class II
- Regulation Number
- 870.1310
- Review Panel
- CV
- Submission Type