Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012159165

FEI Number

3012159165

Entity Name

BIOMERICS Advanced Catheter

City/State/Country

Brooklyn Park, MN, US

Establishment Address

10351 Xylon Avenue N, Brooklyn Park, MN 55445, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Biomerics (Owner Number: 10042380)

Owner / Operator Contact Address

6030 W Harold Gatty Drive, Salt Lake City, UT 84116, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221390

PMA Number

N/A

All Registered Proprietary Names

TalWire FLEX Scoring Catheter pREBOA-PRO Catheter ArcTV Transvaginal Sling System Mcompass Biofeedback Anorectal Manometry System Biomerics NLE Access Guidewire

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2023-07-27
PNO	Catheter, Percutaneous, Cutting/Scoring	Cardiovascular	Class 2	870.1250	2020-02-25
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2020-06-24
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2020-06-24
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2020-06-24
OTN	Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	General, Plastic Surgery	Class 2	878.3300	2020-06-24
KLA	Monitor, Esophageal Motility, Anorectal Motility, And Tube	Gastroenterology, Urology	Class 2	876.1725	2015-11-05
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2023-07-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Biomerics

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3016079756	Biomerics NLE	Monroe, CT, US
3026390991	Biomerics Dominican Republic	Haina San Cristobal, DO
3014246639	Biomerics Cartago	Cartago, CR
3008998256	BIOMERICS	Salt Lake City, UT, US
3003678543	Biomerics Alajuela	ALAJUELA, CR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150445	Asahi Intecc Co., Ltd.	ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)	2015-06-30
K082922	Lake Region Mfg., Inc.	FREEWAY AND RAILRUNNER GUIDEWIRES	2008-12-09
K890207	E-Z-Em, Inc.	INTERVENTIONAL PRODUCTS - GUIDE WIRES	1989-05-31
K992169	Advanced Cardiovascular Systems, Inc.	ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE	1999-10-28
K012534	Advanced Cardiovascular Systems, Inc.	HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING	2002-01-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012159165. Last updated year: 2026. Please use registration number 3012159165 when referencing this establishment in official correspondence.