510(k) K181905
K181905 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System". The FDA issued a decision of Substantially Equivalent on March 25, 2019. The device falls under product code PCU (Pancreatic Stent, Covered, Metallic, Removable), a Class II device regulated under 21 CFR 876.5015. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 25, 2019
- Date Received
- July 16, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pancreatic Stent, Covered, Metallic, Removable
- Device Class
- Class II
- Regulation Number
- 876.5015
- Review Panel
- GU
- Submission Type
To facilitate transmural endoscopic drainage of pancreatic pseudocysts