510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K101017Substantially Equivalent

Angiodynamics, Inc., Smart Port CT Series Port Access Systems

Boston Scientific Corporation, Queensburgy NY / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K101017 is the FDA 510(k) clearance record for ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS, a class II device, cleared for AngioDynamics, Inc. on under FDA product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K101017.

Clearance record

Decision date
Received
(66 days to decision)
Product code
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Regulation
21 CFR 880.5965
Device class
Class II
Review panel
General Hospital
Applicant
AngioDynamics, Inc. 603 Queensbury Ave., Queensburgy NY
510(k) summary
Statement
Third party review
No

Clearances, product code LJT

Trailing 12 months
1 clearance under product code LJT in the twelve months to November 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LJT, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260
November 20260