Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3035111606

FEI Number

3035111606

Entity Name

GAMAMED VASCULAR SYSTEMS INC.

City/State/Country

Loveland, CO, US

Establishment Address

815 14Th Street SW, Suite C250, Loveland, CO 80537, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

Gamamed Vascular Systems Inc. (Owner Number: 10092344)

Owner / Operator Contact Address

815 14Th Street SW, Suite C250, Loveland, CO 80537, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K101329

PMA Number

N/A

All Registered Proprietary Names

Clear Embolectomy Catheter ENERGY-CT-PICC Peripherally Inserted Central Catheter (PICC), single, double and triple lumen Atlantis Pro Anesthesia Machine Volta Pro Anesthesia Machine Atlantis Anesthesia Machine Volta Anesthesia Machine Aspen Pro Patient Monitor Aspen Patient Monitor Eve Pro Operation Table Eve Operation Table Gina Operation Table Vail Surgical Lamp 700/700 Vail Mobile Surgical Lamp 520 Vail Mobile Surgical Lamp 720/720 Vail Surgical Lamp 700 Vail Mobile Surgical Lamp 700 Vail Mobile Surgical Lamp 500 Vail Surgical Lamp 500 Vail Mobile Surgical Lamp 720 Vail Surgical Lamp 700/500 Vail Mobile Surgical Lamp 720/520 Lotus Central Venous Catheter Orbic Hemodialysis Catheter Twinflow Pediatric HC Vigor Bipolar Pacing Catheter Swift Peripheral IV Catheter Colorado Introducer Sheath Access Sets Veinglide Midline Catheter Energy CT Midline Catheter Mini Veinglide Mini Midline Catheter Dialycath Peritoneal Dialysis Catheter HOG Luer Lock Syringe Energy PICC CT Peripherally Inserted Central Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXE	Catheter, Embolectomy	Cardiovascular	Class 2	870.5150	2025-07-22
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2025-01-23
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2025-09-24
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2025-09-24
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2025-09-24
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2025-09-24
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2025-09-24
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2025-09-24
FQO	Table, Operating-Room, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2025-09-24
FQP	Lamp, Operating-Room	General, Plastic Surgery	Class 2	878.4580	2025-09-24
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2024-12-29
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2024-12-29
MSD	Catheter, Hemodialysis, Implanted	Gastroenterology, Urology	Class 2	876.5540	2025-07-22
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2025-07-21
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2025-07-22
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2026-04-03
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2025-07-22
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2025-07-22
MEG	Syringe, Antistick	General Hospital	Class 2	880.5860	2025-07-22
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2025-07-22
LJS	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	General Hospital	Class 2	880.5970	2025-07-24

Official Correspondent

Lorena Arrieche

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Gamamed Vascular Systems Inc.

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
K252746	Drägerwerk AG Co. Kgaa	Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)	2026-05-21
K071802	Mammendorfer Institut Fur Physik Und Medizin GmbH	TESLA GUARD, MODEL EFT G04	2007-11-09
K124061	Invivo Corporation	MRI PATIENT MONITORING SYSTEM (MODEL 865214)	2013-02-22
K101264	Remote Diagnostic Technologies , Ltd.	TEMPUS IC PROFESSIONAL PATIENT MONITOR	2010-05-11

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 3035111606. Last updated year: 2026. Please use registration number 3035111606 when referencing this establishment in official correspondence.