510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K152261Substantially Equivalent

PICC Tip Positioning Aid

Nostix, LLC, Boulder CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K152261 is the FDA 510(k) clearance record for PICC Tip Positioning Aid, a class II device, cleared for Nostix, LLC on under FDA product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days). FDA records list one 510(k) clearance for Nostix, LLC. As of , FDA records show no recalls naming K152261.

Clearance record

Decision date
Received
(71 days to decision)
Product code
LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Regulation
21 CFR 880.5970
Device class
Class II
Review panel
General Hospital
Applicant
Nostix, LLC 5541 Central Ave., Suite 170, Boulder CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LJS

Trailing 12 months
4 clearances under product code LJS in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LJS, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20261