System, Catheter Or Guidewire, Steerable (Magnetic)
The System, Catheter Or Guidewire, Steerable (Magnetic) (product code NDQ) is a cardiovascular device that uses magnetic steering to guide a catheter or guidewire through vascular structures, enabling navigation of complex anatomies. It is an FDA Class 2 device within the Cardiovascular specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- NDQ
- Device Class
- FDA class 2
- Regulation Number
- 870.1290
- Medical Specialty
- Cardiovascular
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.