510(k) K945909
K945909 is an FDA 510(k) premarket notification submitted by Navarre Biomedical , Ltd. for the device "NAVARRE N-FUSER(TM) PERIPHERAL INFUSION CATHETER". The FDA issued a decision of Substantially Equivalent on June 2, 1995. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Navarre Biomedical , Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 2, 1995
- Date Received
- December 2, 1994
- 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