510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K220171Substantially Equivalent

NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter

Northeast Scientific Inc., Waterbury CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K220171 is the FDA 510(k) clearance record for NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter, a class II device, cleared for Northeast Scientific, Inc. on under FDA product code QTF (Reprocessed Atherectomy Catheter). FDA's definition for product code QTF reads: "Reprocessed atherectomy device for peripheral vasculature. Reprocessing validation data for this device type must be included in a 510(k) submission". FDA records list 6 510(k) clearances for Northeast Scientific, Inc., from to . As of , FDA records show one recall naming K220171.

Clearance record

Decision date
Received
(161 days to decision)
Product code
QTF Reprocessed Atherectomy Catheter
Regulation
21 CFR 870.4875
Device class
Class II
Review panel
Cardiovascular
Applicant
Northeast Scientific, Inc. 2142 Thomaston Ave., Waterbury CT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QTF

Trailing 12 months

FDA records hold no clearances under product code QTF in the trailing twelve months.

FDA records show no clearances under product code QTF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QTF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260