Data / Medical devices / United States / BIOMERICS Advanced Catheter

BIOMERICS Advanced Catheter: FDA-registered device maker in Brooklyn Park, MN, United States, 1 510(k) clearance

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

BIOMERICS Advanced Catheter is registered with the FDA (registration 3012159165) in Brooklyn Park, MN, United States. It lists 7 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 28, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012159165
Address: 10351 Xylon Avenue N, Brooklyn Park, MN, United States, 55445
Owner or operator: Biomerics (10042380)
Roles: Contract manufacturer, Manufacturer
First device listed: November 5, 2015
Registered through: 2026
Brand names listed: ArcTV Transvaginal Sling System, Biomerics NLE Access Guidewire, FLEX Scoring Catheter, FLEX Vessel Prep System, Mcompass Biofeedback Anorectal Manometry System, Sublime Microcatheter, TalWire, pREBOA-PRO Catheter

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Intravascular Occluding, Temporary	MJN	2	Contract manufacturer	accessdata.fda.gov
Catheter, Intravascular, Diagnostic	DQO	2	Contract manufacturer	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Contract manufacturer	accessdata.fda.gov
Catheter, Percutaneous, Cutting/Scoring	PNO	2	Contract manufacturer	accessdata.fda.gov
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	OTN	2	Contract manufacturer	accessdata.fda.gov
Monitor, Esophageal Motility, Anorectal Motility, And Tube	KLA	2	Contract manufacturer	accessdata.fda.gov
Wire, Guide, Catheter	DQX	2	Contract manufacturer, Manufacturer	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
April 28, 2023	K221390	BNLE Access Guidewire	DQX	Substantially Equivalent	Biomerics Nle	accessdata.fda.gov

Compare with other makers

Updated April 28, 2023. 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.