510(k) K034036
K034036 is an FDA 510(k) premarket notification submitted by Micro Therapeutics, Inc. for the device "MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055". The FDA issued a decision of Substantially Equivalent on February 13, 2004. The device falls under product code KRA (Catheter, Continuous Flush), a Class II device regulated under 21 CFR 870.1210. Micro Therapeutics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 2004
- Date Received
- December 29, 2003
- 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