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))
| Device Type ID | 983 |
| Device Name | Syringe, Balloon Inflation, Exempt |
| Physical State | Exemption Is Limited To Non-patient Contacting Balloon Inflation Syringes Intended Only To Inflate/deflate Balloon Catheters And Monitor Pressure Within The Balloon. |
| Technical Method | 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)) |
| Target Area | 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)) |
| Regulation Description | Angiographic Injector And Syringe. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Interventional Cardiology Devices Branch (ICDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 870.1650 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PTM |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 983 |
| Device | Syringe, Balloon Inflation, Exempt |
| Product Code | PTM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Angiographic Injector And Syringe. |
| CFR Regulation Number | 870.1650 [🔎] |