510(k) K130649
K130649 is an FDA 510(k) premarket notification submitted by Silk Road Medical, Inc. for the device "SILK ROAD ACCESS CATHETER". The FDA issued a decision of Substantially Equivalent on November 1, 2013. The device falls under product code DQY (Catheter, Percutaneous), a Class II device regulated under 21 CFR 870.1250. Silk Road Medical, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 1, 2013
- Date Received
- March 11, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Percutaneous
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type