Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015537049

FEI Number

3015537049

Entity Name

ANGIODYNAMICS, INC

City/State/Country

Queensbury, NY, US

Establishment Address

24 Native Dr, --, Queensbury, NY 12804, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

ANGIODYNAMICS, INC (Owner Number: 9028212)

Owner / Operator Contact Address

26 Forest St., --, Marlborough, MA 01752, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K033473

PMA Number

N/A

All Registered Proprietary Names

Xcela Plus Port with PASV Valve Technology BioFlo Port with ENDEXO Technology BioFlo Port with ENDEXO and PASV Valve Technology Xcela Plus Port AngioVac Circuit Pack Xcela Power Injectable PICC Maximal Barrier Nursing Kit 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 NAVILYST MEDICAL PICC CONVENIENCE KIT Smart Port CT Low-Profile Smart Port CT Mini Smart Port CT Vortex MP Vascular Access Port

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2017-05-09
DWE	Tubing, Pump, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4390	2015-05-18
PND	Midline Catheter	General Hospital	Class 2	880.5200	2017-05-09
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2017-05-09
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2016-07-18
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2010-06-30
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2008-07-21
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-07-21
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2008-01-22

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ANGIODYNAMICS, INC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1000523114	AngioDynamics, Inc.	Marlborough, MA, US
1319211	ANGIODYNAMICS, INC.	Queensbury, NY, US
3017892510	ANGIODYNAMICS, INC	Glens Falls, NY, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K912423	Med Institute, Inc.	VITAL-PORT M.R.I. VASCULAR ACCESS SYSTEM 7012,7112	1991-07-30
K961652	Arrow Intl., Inc.	LOW PROFILE PLASTIC PORT DETACHED CATHETER SYSTEM CATALOG #1017	1996-07-19
K893460	Therex Corp.	A-PORT IMPLANT VASCULAR ACCESS SYSTEM .6MM/2.29MM	1989-06-23
K233702	LivaNova USA, Inc.	SMARxT Tubing and Connectors	2024-08-08
K971999	B.Braun Medical, Inc.	PERIPHERALLY INSERTED CENTRAL	1997-11-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2011	Maquet Inc.	2	MAQUET HLM Tubing set with Bioline Coating (BEQ-TOP 21400 with 1/2 x 1/2 HG 0286 Connector; Device Part Number BEQ-TOP 21400
Z-0001-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnostic Intravascular Catheter
Z-0004-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0025-2015	Navilyst Medical, Inc	2	BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 3F-55 cm, UPN Product No. H965750231, REF/Catalog No. 75-023, STERILE --- Intended for short or long term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.
Z-0026-2015	Navilyst Medical, Inc	2	BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catalog No. 75-019, STERILE --- Indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood and for power injection of contrast media.

Similar Registrations

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9681202	pfm medical cpp SA	LA CHAUX-DE-FONDS Neuchatel, CH
9617604	ICU Medical Healthcare Manufacturing S.A. de C.V.	Tijuana, B.C. C.P. Baja California, MX
1000523114	AngioDynamics, Inc.	Marlborough, MA, US
1319211	ANGIODYNAMICS, INC.	Queensbury, NY, US
3013750125	Medical Components, Inc.	Yuma, AZ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015537049. Last updated year: 2026. Please use registration number 3015537049 when referencing this establishment in official correspondence.