510(k) K181382
K181382 is an FDA 510(k) premarket notification submitted by St Jude Medical for the device "GuardianTM Burr Hole Cover System". The FDA issued a decision of Substantially Equivalent on July 20, 2018. The device falls under product code GXR (Cover, Burr Hole), a Class II device regulated under 21 CFR 882.5250. St Jude Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 20, 2018
- Date Received
- May 25, 2018
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cover, Burr Hole
- Device Class
- Class II
- Regulation Number
- 882.5250
- Review Panel
- NE
- Submission Type