510(k) K031992
K031992 is an FDA 510(k) premarket notification submitted by Micro Therapeutics, Inc. for the device "ECHELON MICRO CATHETER, MODEL 105-5091". The FDA issued a decision of Substantially Equivalent on August 7, 2003. 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
- August 7, 2003
- Date Received
- June 27, 2003
- Clearance Type
- Special
- 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