Syringe, Balloon Inflation, Exempt
The Syringe, Balloon Inflation (Exempt) is a cardiovascular device used to inflate balloon catheters during interventional procedures such as angioplasty or valvuloplasty. Product code PTM is the Class II exempt counterpart of MAV, exempted from premarket notification (510(k)) requirements under the 21st Century Cures Act, subject to the limitations in 21 CFR 870.9. As a Class II device under regulation 21 CFR 870.1650, it is subject to general and special controls but may be marketed without a 510(k) if it does not exceed the limitations of exemption. It falls under the Cardiovascular medical specialty and is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- PTM
- Device Class
- FDA class 2
- Regulation Number
- 870.1650
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 4
Device Characteristics
Definition
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.
FEI Numbers
This FDA classification entry is associated with 58 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 58 registration numbers. Click on an entry to view related FDA registrations.