FDA product code MAV: Syringe, Balloon Inflation
MAV is the FDA product code for syringe, balloon inflation. It is a Class II device, regulated under 21 CFR 870.1650 and reviewed by the Cardiovascular panel. FDA has cleared 58 510(k) submissions under MAV, 2 in the last five years, from 41 different applicants. The average 510(k) review took 123 days (median 108); 241 days on average over the last three years. FDA has posted 29 recalls for MAV devices, 10 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Syringe, Balloon Inflation |
| Device class | Class II |
| Regulation | 21 CFR 870.1650 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MAV
| Year | Clearances | Avg. review days |
|---|---|---|
| 2022 | 1 | 28 |
| 2026 | 1 | 241 |
Compare with all 510(k) review times · Search every MAV clearance
Top MAV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Merit Medical Systems, Inc. | 6 | 2016-01-20 |
| Boston Scientific Corp | 5 | 2014-04-17 |
| Advanced Cardiovascular Systems, Inc. | 4 | 1996-09-12 |
| Vascular Solutions, Inc. | 2 | 2016-10-20 |
| Medtronics Interventional Vascular | 2 | 1996-05-30 |
36 more applicants have MAV clearances. See the full list in Caduvo.
Most recent MAV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260035 | UAB Telemedicina | Digital Indeflator INFLANTE | 2026-09-04 | 241 |
| K220773 | Medtronic Vascular | Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P) | 2022-04-13 | 28 |
| K162272 | Vascular Solutions, Inc. | Fluent inflation device | 2016-10-20 | 69 |
| K153038 | Medtronic, Inc. | Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit | 2016-04-13 | 177 |
| K153672 | Merit Medical Systems, Inc. | basixTOUCH40 Inflation Syringe | 2016-01-20 | 30 |
Recalls for MAV devices
29 product recalls in 15 recall events; 10 initiated in the last five years and 10 still open. Most recent: 2025-08-05.
| Year | Recalls |
|---|---|
| 2017 | 4 |
| 2018 | 1 |
| 2022 | 5 |
| 2024 | 4 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code MAV?
MAV is the FDA product code for syringe, balloon inflation. It is a Class II device, regulated under 21 CFR 870.1650 and reviewed by the Cardiovascular panel.
What device class is MAV?
Class II, regulation 21 CFR 870.1650. Typical premarket route: 510(k).
How long does a 510(k) take for product code MAV?
Across 58 cleared submissions the average was 123 days from receipt to decision (median 108).
Which companies have the most MAV clearances?
Merit Medical Systems, Inc. (6); Boston Scientific Corp (5); Advanced Cardiovascular Systems, Inc. (4); Vascular Solutions, Inc. (2); Medtronics Interventional Vascular (2).
Have MAV devices been recalled?
Yes: 29 product recalls across 15 recall events; the most recent began 2025-08-05.
Next steps
- Run an FDA pathway report with predicate devices for product code MAV
- Run a recall and safety report across every MAV manufacturer
- Watch product code MAV for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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