510(k) K090999
K090999 is an FDA 510(k) premarket notification submitted by Biocardia, Inc. for the device "BIOCARDIA MORPH SHEATH GUIDE". The FDA issued a decision of Substantially Equivalent on April 15, 2009. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Biocardia, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 15, 2009
- Date Received
- April 8, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Introducer, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type