510(k) K870700
K870700 is an FDA 510(k) premarket notification submitted by Catheter Research C/O Burditt, Bowles & Radzius for the device "MICRO-GUIDE". The FDA issued a decision of Substantially Equivalent on December 3, 1987. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Catheter Research C/O Burditt, Bowles & Radzius has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 1987
- Date Received
- February 19, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Diagnostic
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type