Data / Medical devices / United States / Gamamed Vascular Systems Inc.
Gamamed Vascular Systems Inc.: FDA-registered device maker in Loveland, CO, United States, 20 510(k) clearances
Gamamed Vascular Systems Inc. is registered with the FDA (registration 3035111606) in Loveland, CO, United States. It lists 22 device types. The FDA files 20 510(k) clearances under its listings, the newest dated June 15, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3035111606
- Address
- 815 14Th Street SW, Suite C250, Loveland, CO, United States, 80537
- Owner or operator
- Gamamed Vascular Systems Inc. (10092344)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- December 29, 2024
- Registered through
- 2026
- Brand names listed
- Alfa Central Venous Catheter Sets, Arterioglide Arterial Catheter, Aspen Patient Monitor, Aspen Pro Patient Monitor, Atlantis Anesthesia Machine, Atlantis Pro Anesthesia Machine, Clear Embolectomy Catheter, Colorado Introducer Sheath Access Sets and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| June 15, 2025 | K242863 | Bioptimal Bipolar Pacing Catheter | LDF | Substantially Equivalent | Bioptimal International Pte. , Ltd. | accessdata.fda.gov |
| May 16, 2025 | K241581 | Hemodialysis Catheter | MSD | Unknown | Haolang Medical USA Corporation | accessdata.fda.gov |
| March 1, 2022 | K211484 | Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles | MEG | Substantially Equivalent | Shinva Ande Healthcare Apparatus Co., Ltd. | accessdata.fda.gov |
| July 23, 2021 | K202060 | Disposable IV catheter | FOZ | Substantially Equivalent | Shinva Ande Healthcare Apparatus Co., Ltd. | accessdata.fda.gov |
| July 7, 2021 | K201726 | Arterial Catheter | DQY | Substantially Equivalent | Haolang Medical USA Corporation | accessdata.fda.gov |
| May 6, 2021 | K201697 | Umbilical Vessels Catheter | FOS | Substantially Equivalent | Haolang Medical USA Corporation | accessdata.fda.gov |
| December 31, 2019 | K192343 | Patient Monitor | DQA | Substantially Equivalent | Shenzhen Creative Industry Co., Ltd. | accessdata.fda.gov |
| October 5, 2017 | K172099 | Shoocin Introducer Kit | DYB | Substantially Equivalent | Lepu Medical Technology (Beijing) Co., Ltd. | accessdata.fda.gov |
| May 31, 2017 | K162601 | Infusion Set for Single Use | FPA | Substantially Equivalent | Shinva Ande Healthcare Apparatus Co., Ltd. | accessdata.fda.gov |
| August 20, 2014 | K140270 | NEXUS MIDLINE CT CATHETER | FOZ | Substantially Equivalent | Health Line International Corporation | accessdata.fda.gov |
| May 9, 2014 | K131790 | A9800 ANESTHESIA WORKSTATION | BSZ | Substantially Equivalent | Oricare, Inc. | accessdata.fda.gov |
| August 13, 2013 | K123473 | HOPER PTCA BALLOON CATHETER | LOX | Substantially Equivalent | Lepu Medical Technology (Beijing) Co., Ltd. | accessdata.fda.gov |
| April 2, 2013 | K123943 | AMECATH DUAL LUMEN HEMODIALYSIS CATHETER | MSD | Substantially Equivalent | Ameco Medical Industries | accessdata.fda.gov |
| March 8, 2013 | K130034 | UNI-PICC | LJS | Substantially Equivalent | Health Line International Corporation | accessdata.fda.gov |
| May 18, 2012 | K113622 | ORION II CT CVC | FOZ | Substantially Equivalent | Health Line International Corporation (Hlic) | accessdata.fda.gov |
| November 18, 2011 | K102833 | DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS | MPB | Substantially Equivalent | Foshan Nanhai Bai HE Medical Technology Co., Ltd. | accessdata.fda.gov |
| August 19, 2010 | K101329 | SYNERGY CT PICC | LJS | Substantially Equivalent | Health Line International Corporation | accessdata.fda.gov |
| July 31, 2007 | K070451 | ABLE CENTRAL VENOUS CATHETER | FOZ | Substantially Equivalent | Foshan Nanhai Bai HE Medical Technology Co., Ltd. | accessdata.fda.gov |
| November 17, 2000 | K002786 | BIOSENSORS CENTRAL VENOUS CATHETER KITS | FOZ | Substantially Equivalent | Sunscope Intl., Inc. | accessdata.fda.gov |
| September 4, 1998 | K973477 | BIOSENSORS EMBOLECTOMY CATHETER | DXE | Substantially Equivalent | Sunscope Intl., Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- All makers of Catheter, Umbilical Artery
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Piston
- All makers of Syringe, Antistick
- All makers of Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Updated June 15, 2025. 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.