MAVClass II
Syringe, Balloon Inflation
21 CFR 870.1650 / Cardiovascular
MAV is the FDA product code for Syringe, Balloon Inflation, a class II device type, regulated under 21 CFR 870.1650. As of , FDA records hold 57 510(k) clearances under this code, the most recent dated , and 29 recalls.
Classification record
- Product code
- MAV
- Device name
- Syringe, Balloon Inflation
- Regulation
- 21 CFR 870.1650
- Device class
- Class II
- Review panel
- Cardiovascular
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 58
- Ingested recalls
- 29
Clearances, product code MAV
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 1983 | 1 |
| 1984 | 1 |
| 1985 | 1 |
| 1986 | 1 |
| 1989 | 1 |
| 1990 | 7 |
| 1991 | 8 |
| 1992 | 3 |
| 1993 | 1 |
| 1994 | 3 |
| 1995 | 2 |
| 1996 | 6 |
| 1999 | 1 |
| 2002 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2008 | 1 |
| 2011 | 1 |
| 2012 | 4 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 3 |
| 2016 | 3 |
| 2022 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code MAV| Applicant | Clearances |
|---|---|
| Merit Medical Systems, Inc. | 6 |
| Boston Scientific Corporation | 5 |
| Advanced Cardiovascular Systems, Inc. | 4 |
| Medtronic, Inc. | 2 |
| Medtronics Interventional Vascular | 2 |
| Professional Medical Services | 2 |
| Scimed Life Systems, Inc. | 2 |
| Vascular Solutions LLC | 2 |
| Allied Systems Co. | 1 |
| American Edwards Laboratories | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.