510(k) K040138
K040138 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "VICEROY INFLATION DEVICE". The FDA issued a decision of Substantially Equivalent on February 13, 2004. The device falls under product code MAV (Syringe, Balloon Inflation), a Class II device regulated under 21 CFR 870.1650. Merit Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 2004
- Date Received
- January 22, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Syringe, Balloon Inflation
- Device Class
- Class II
- Regulation Number
- 870.1650
- Review Panel
- CV
- Submission Type