Septostomy Catheter, Reprocessed
The Septostomy Catheter (Reprocessed) is a cardiovascular device intended to create or enlarge an atrial septal defect in the heart, a procedure used in certain congenital heart conditions to improve blood mixing or oxygen delivery. As a reprocessed single-use device, it must demonstrate that reprocessing does not compromise safety or efficacy. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 870.5175 in the Cardiovascular specialty. It carries product code QLZ and is GMP exempt. It is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QLZ
- Device Class
- FDA class 2
- Regulation Number
- 870.5175
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
Definition
To create or enlarge an atrial septal defect in the heart.
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.