FDA product code PTL: Wire, Guide, Catheter, Exempt
PTL is the FDA product code for wire, guide, catheter, exempt. It is a Class II device, regulated under 21 CFR 870.1330 and reviewed by the Cardiovascular panel. Devices under PTL reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
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)) 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.
Classification
| Field | Value |
|---|---|
| Device name | Wire, Guide, Catheter, Exempt |
| Device class | Class II |
| Regulation | 21 CFR 870.1330 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Recalls for PTL devices
openFDA lists no recalls for product code PTL.
Frequently asked questions
What is FDA product code PTL?
PTL is the FDA product code for wire, guide, catheter, exempt. It is a Class II device, regulated under 21 CFR 870.1330 and reviewed by the Cardiovascular panel.
What device class is PTL?
Class II, regulation 21 CFR 870.1330. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code PTL
- Run a recall and safety report across every PTL manufacturer
- Watch product code PTL 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.