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

Reprocessed Atherectomy Catheter

21 CFR 870.4875 / Cardiovascular
FDA source (opens on fda.gov)

QTF is the FDA product code for Reprocessed Atherectomy Catheter, a class II device type, regulated under 21 CFR 870.4875. FDA's definition for this code reads: "Reprocessed atherectomy device for peripheral vasculature. Reprocessing validation data for this device type must be included in a 510(k) submission". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and 8 recalls.

Classification record

Product code
QTF
Device name
Reprocessed Atherectomy Catheter
FDA definition
Reprocessed atherectomy device for peripheral vasculature. Reprocessing validation data for this device type must be included in a 510(k) submission
Regulation
21 CFR 870.4875
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
8

Clearances, product code QTF

By decision year
1 clearance under product code QTF with a decision year between 2022 and 2022, 2022 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QTF by decision year
YearClearances
20221

Applicants with the most clearances

Product code QTF
Applicants holding the most 510(k) clearances under product code QTF
ApplicantClearances
Northeast Scientific Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code