510(k) K012749
K012749 is an FDA 510(k) premarket notification submitted by Biocardia, Inc. for the device "BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664". The FDA issued a decision of Substantially Equivalent on January 24, 2002. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Biocardia, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 24, 2002
- Date Received
- August 16, 2001
- 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