Data / Medical devices / United States / Angiodynamics, Inc

Angiodynamics, Inc: FDA-registered device maker in Queensbury, NY, United States, 7 510(k) clearances

Name: Angiodynamics, Inc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Angiodynamics, Inc is registered with the FDA (registration 3015537049) in Queensbury, NY, United States. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated February 3, 2017. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3015537049
Address: 24 Native Dr --, Queensbury, NY, United States, 12804
Owner or operator: ANGIODYNAMICS, INC (9028212)
Roles: Repackager or relabeler
First device listed: January 22, 2008
Registered through: 2026
Brand names listed: AngioVac Circuit Pack, BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology-Maximal Barrier Nursing Kit, BioFlo PICC with ENDEXO Technology-Maximal Barrier Nursing Kit, BioFlo PICC with ENDEXO and PASV Valve Technology-Maximal Barrier Nursing Kit, BioFlo Port with ENDEXO Technology, BioFlo Port with ENDEXO and PASV Valve Technology, NAVILYST MEDICAL PICC CONVENIENCE KIT, Smart Port CT and more

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	LJS	2	Repackager or relabeler	accessdata.fda.gov
Midline Catheter	PND	2	Repackager or relabeler	accessdata.fda.gov
Port & Catheter, Implanted, Subcutaneous, Intravascular	LJT	2	Repackager or relabeler	accessdata.fda.gov
Set, Administration, Intravascular	FPA	2	Repackager or relabeler	accessdata.fda.gov
Tubing, Pump, Cardiopulmonary Bypass	DWE	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 3, 2017	K163452	PICC Maximal Barrier Nursing Kit	LJS	Unknown	Navilyst Medical, Inc.	accessdata.fda.gov
December 4, 2015	K153228	NMI Port, NMI Port II	LJT	Substantially Equivalent	Navilyst Medical, Inc.	accessdata.fda.gov
December 11, 2014	K142607	AngioVac Circuit	DWE	Substantially Equivalent	Angiodynamics	accessdata.fda.gov
August 3, 2012	K121990	PICC CONVENIENCE KIT	LJS	Substantially Equivalent	Navilyst Medical, Inc.	accessdata.fda.gov
June 17, 2010	K101017	ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS	LJT	Substantially Equivalent	AngioDynamics, Inc.	accessdata.fda.gov
February 1, 2007	K062414	VORTEX CT PORT ACCESS SYSTEM AND LIFEGUARD SAFETY INFUSION SET	LJT	Substantially Equivalent	Rita Medical Systems, Inc.	accessdata.fda.gov
November 18, 2003	K033473	MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT	LJT	Substantially Equivalent	Horizon Medical Products, Inc.	accessdata.fda.gov

Compare with other makers

Updated February 3, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.