510(k) K081625
K081625 is an FDA 510(k) premarket notification submitted by Vasonova, Inc. for the device "FLOWPICC STYLET". The FDA issued a decision of Substantially Equivalent on September 26, 2008. The device falls under product code OBJ (Catheter, Ultrasound, Intravascular), a Class II device regulated under 21 CFR 870.1200. Vasonova, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 2008
- Date Received
- June 10, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Ultrasound, Intravascular
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.