Wire, Guide, Catheter, Exempt
The Wire, Guide, Catheter (Exempt) is a cardiovascular catheter guidewire used to navigate catheters through the vascular system during interventional procedures. This product code (PTL) is the Class II exempt counterpart of product code DQX, and was exempted from the premarket notification (510(k)) requirement under procedures established by the 21st Century Cures Act, subject to the limitations of exemption in 21 CFR 870.9. As a Class II device under regulation 870.1330, it must still comply with general and special controls but does not require a 510(k) submission as long as it does not exceed the specified limitations. It falls under the Cardiovascular medical specialty and is not flagged as an implant or life-sustaining device.
Research product code PTL in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- PTL
- Device Class
- FDA class 2
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 4
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 34 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 34 registration numbers. Click on an entry to view related FDA registrations.