QLZ — Septostomy Catheter, Reprocessed Class II
FDA product code QLZ covers "Septostomy Catheter, Reprocessed", a Class II medical device regulated under 21 CFR 870.5175. Submissions are reviewed by the Cardiovascular panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QLZ
- Device Class
- Class II
- Regulation Number
- 870.5175
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
To create or enlarge an atrial septal defect in the heart.