MAV — Syringe, Balloon Inflation Class II
FDA product code MAV covers "Syringe, Balloon Inflation", a Class II medical device regulated under 21 CFR 870.1650. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MAV
- Device Class
- Class II
- Regulation Number
- 870.1650
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K220773 | medtronic vascular | Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Dev | April 13, 2022 |
| K162272 | vascular solutions | Fluent inflation device | October 20, 2016 |
| K153038 | medtronic | Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disp | April 13, 2016 |
| K153672 | merit medical systems | basixTOUCH40 Inflation Syringe | January 20, 2016 |
| K152387 | vascular solutions | Fluent Inflation Device | December 18, 2015 |
| K140943 | beijing demax medical technology co | MASTRO PLUS BALLOON IN-DEFLATION DEVICE | March 5, 2015 |
| K143522 | c.r. bard | Presto Inflation Device | January 12, 2015 |
| K133795 | sunny medical device (shenzhen) co | SUMMED INFLATION DEVICE KIT | December 12, 2014 |
| K140745 | boston scientific | ENCORE 26 ADVANTAGE KIT | April 17, 2014 |
| K130566 | merit medical systems | BASIXTOUCH | June 19, 2013 |
| K122321 | merit medical ireland | BASIXCONPAK ANALOG INFLATION SYRINGE | December 19, 2012 |
| K122152 | oxti corporation | OXTI INFLATION DEVICE | December 14, 2012 |
| K123214 | boston scientific | ENCORE 26 ADVANTAGE KIT | November 13, 2012 |
| K120694 | boston scientific | ENCORE 26 ADVANTAGE KIT | April 3, 2012 |
| K102648 | shenzhen ant hi-tech industrial co | ANT INFLATION DEVICE/ANT INFLATION DEVICE COMPACT PACK | July 1, 2011 |
| K082755 | sedat | SEDAT FLAMINGO | December 15, 2008 |
| K060643 | atrion medical products | QL LOCKING SYRINGE | July 12, 2006 |
| K042449 | sedat | DOLPHIN INFLATION DEVICE | April 18, 2005 |
| K040138 | merit medical systems | VICEROY INFLATION DEVICE | February 13, 2004 |
| K012480 | vanguard medical concepts | VANGUARD REPROCESSED INFLATION DEVICES | January 22, 2002 |