510(k) K182442
K182442 is an FDA 510(k) premarket notification submitted by Quest Medical, Inc. for the device "MiniGuard Arterial Safety Valve". The FDA issued a decision of Substantially Equivalent on November 6, 2018. The device falls under product code MJJ (Cpb Check Valve, Retrograde Flow, In-Line), a Class II device regulated under 21 CFR 870.4400. Quest Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 6, 2018
- Date Received
- September 7, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cpb Check Valve, Retrograde Flow, In-Line
- Device Class
- Class II
- Regulation Number
- 870.4400
- Review Panel
- CV
- Submission Type