PTM · Syringe, Balloon Inflation, Exempt
Cardiovascular · 21 CFR 870.1650 · Class 2
Overview
| Product Code | PTM |
|---|---|
| Device Name | Syringe, Balloon Inflation, Exempt |
| Regulation | 21 CFR 870.1650 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
Identification
This product code is the class II exempt counterpart of MAV, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 870.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.
Special Controls
*Classification.* Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
Recent Cleared Devices (0 of 0)
No cleared devices on record.
