510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K001578Substantially Equivalent

Angiodynamics Soft-Vu Hydrophilic Coated Angiographic Catheter

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

K001578 is the FDA 510(k) clearance record for ANGIODYNAMICS SOFT-VU HYDROPHILIC COATED ANGIOGRAPHIC CATHETER, a class II device, cleared for AngioDynamics, Inc. on under FDA product code DQO (Catheter, Intravascular, Diagnostic). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show one recall naming K001578.

Clearance record

Decision date
Received
(144 days to decision)
Product code
DQO Catheter, Intravascular, Diagnostic
Regulation
21 CFR 870.1200
Device class
Class II
Review panel
Cardiovascular
Applicant
AngioDynamics, Inc. 603 Queensbury Ave., Queensburgy NY
510(k) summary
Statement
Third party review
No

Clearances, product code DQO

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