510(k) K123477
K123477 is an FDA 510(k) premarket notification submitted by Sequent Medical, Inc. for the device "VIA MICROCATHETER, VIA PLUS MICROCATHETER". The FDA issued a decision of Substantially Equivalent on March 19, 2013. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Sequent Medical, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 2013
- Date Received
- November 13, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Continuous Flush
- Device Class
- Class II
- Regulation Number
- 870.1210
- Review Panel
- CV
- Submission Type