Definition: This Product Code Is The Class II Exempt Counterpart Of DQX, 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 | 982 |
| Device Name | Wire, Guide, Catheter, Exempt |
| Physical State | Exemption Is Limited To Accessory Torque Devices That Are Manually Operated, Non-patient Contacting, And Intended To Manipulate Non-cerebral Vascular Guidewires. |
| Technical Method | This Product Code Is The Class II Exempt Counterpart Of DQX, 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 DQX, 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 | Catheter Guide Wire. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Peripheral Interventional Devices Branch (PIDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 870.1330 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PTL |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 982 |
| Device | Wire, Guide, Catheter, Exempt |
| Product Code | PTL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Catheter Guide Wire. |
| CFR Regulation Number | 870.1330 [🔎] |