NKQ — Guidewire, Catheter, Reprocessed Class II
FDA product code NKQ covers "Guidewire, Catheter, Reprocessed", a Class II medical device regulated under 21 CFR 870.1330. Submissions are reviewed by the Cardiovascular panel.
Classification Details
- Product Code
- NKQ
- Device Class
- Class II
- Regulation Number
- 870.1330
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).