Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030714660

FEI Number

3030714660

Entity Name

SPECTRUM VASCULAR

City/State/Country

White Plains, NY, US

Establishment Address

50 Main St. Suite 1000, White Plains, NY 10606, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Spectrum Vascular (Owner Number: 10090343)

Owner / Operator Contact Address

50 Main St. Suite 1000, White Plains, NY 10606, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K180792

PMA Number

N/A

All Registered Proprietary Names

Navilyst Medical PICC Convenience Kit BioFlo PICC with ENDEXO and PASV Valve Technology - Maximal Barrier Nursing Kit BioFlo PICC with ENDEXO Technology - Maximal Barrier Nursing Kit BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology-Maximal Barrier Nursing Kit Xcela Power Injectable PICC Maximal Barrier Nursing Kit BioFlo Midline with ENDEXO Technology Intraosseous Infusion Needle XCELA POWER INJECTABLE PICC BIOFLO PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY BIOFLO PICC WITH ENDEXO TECHNOLOGY BIOFLO HYBRID PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY Bunegin-Albin Air Aspiration Set SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING SPECTRUM SILICONE CATHETER C3 Wave System BioFlo PICC with Endexo and PASV Valve Technology BIOFLO PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY XCELA PICC WITH PASV VALVE TECHNOLOGY XCELA POWER INJECTABLE PICC BIOFLO HYBRID PICC WITH ENDEXO AND PASV VALVE TECHNOLOGY BIOFLO MIDLINE CATHETER BIOFLO PICC WITH ENDEXO TECHNOLOGY Spectrum Vascular Intraosseous Infusion Needles PASV MS Kit with Pressure Activated Safety Valve Spectrum Vascular Unimpregnated Central Venous Catheter Celerity VentriClear II Ventricular Drainage Catheter VentriClear Ventricular Drainage Catheter Set with Spectrum Antibiotic Impregnation Arterial Pressure Monitoring Set/Tray

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2024-03-14
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2024-03-14
PND	Midline Catheter	General Hospital	Class 2	880.5200	2024-03-14
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2024-03-14
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2025-11-25
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2024-03-14
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2024-10-29
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2024-10-29
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2024-10-29
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2024-10-29
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2024-03-14
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2024-03-14
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2026-05-17
PND	Midline Catheter	General Hospital	Class 2	880.5200	2026-05-17
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-10-29
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2024-03-14
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2024-10-29
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2024-10-29
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2024-03-14
NHC	Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)	Neurology	Class 2	882.4100	2024-10-29
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2024-10-29

Official Correspondent

Sharon Klugewicz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Spectrum Vascular

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K971999	B.Braun Medical, Inc.	PERIPHERALLY INSERTED CENTRAL	1997-11-24
K943349	Quinton, Inc.	MAHURKAR DUAL LUMEN CATHETER	1995-03-22
K912158	Medical Device Inspection Co., Inc.	CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY	1991-10-23
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K151126	Colibri Technologies, Inc.	Foresight Intracardiac Echocardiography (ICE) System	2015-12-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0027-2015	Navilyst Medical, Inc	2	BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750141, REF/Catalog No. 75-014, 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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030714660. Last updated year: 2026. Please use registration number 3030714660 when referencing this establishment in official correspondence.