510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QLZClass II

Septostomy Catheter, Reprocessed

21 CFR 870.5175 / Cardiovascular
FDA source (opens on fda.gov)

QLZ is the FDA product code for Septostomy Catheter, Reprocessed, a class II device type, regulated under 21 CFR 870.5175. FDA's definition for this code reads: "To create or enlarge an atrial septal defect in the heart". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QLZ
Device name
Septostomy Catheter, Reprocessed
FDA definition
To create or enlarge an atrial septal defect in the heart.
Regulation
21 CFR 870.5175
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QLZ

By decision year
2 clearances under product code QLZ with a decision year between 2020 and 2023, 2020 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QLZ by decision year
YearClearances
20201
20231

Applicants with the most clearances

Product code QLZ
Applicants holding the most 510(k) clearances under product code QLZ
ApplicantClearances
Innovative Health, LLC.2

Companies listing this code with FDA

Companies whose registered establishments list this code