510(k) K062752
K062752 is an FDA 510(k) premarket notification submitted by Mercator Medsystems, Inc. for the device "MERCATOR MICROSYRINGE II INFUSION CATHETER". The FDA issued a decision of Substantially Equivalent on December 7, 2006. 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
- December 7, 2006
- Date Received
- September 14, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Catheter, Continuous Flush
- Device Class
- Class II
- Regulation Number
- 870.1210
- Review Panel
- CV
- Submission Type