510(k) K161402
K161402 is an FDA 510(k) premarket notification submitted by Mercator Medsystems, Inc. for the device "Bullfrog Micro-Infusion Device". The FDA issued a decision of Substantially Equivalent on August 18, 2016. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Mercator Medsystems, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 18, 2016
- Date Received
- May 20, 2016
- 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