Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030236028

FEI Number

3030236028

Entity Name

Teleflex LLC

City/State/Country

Brooklyn Park, MN, US

Establishment Address

9491 Winnetka Avenue, Brooklyn Park, MN 55445, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Vascular Solutions LLC (Owner Number: 9029941)

Owner / Operator Contact Address

6464 SYCAMORE COURT NORTH, --, Maple Grove, MN 55369, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K043525

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2018-01-05
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2018-06-21
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2019-12-16
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2021-07-14
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-11-04

Official Correspondent

Divya Raman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Vascular Solutions LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2134812	VASCULAR SOLUTIONS LLC	Maple Grove, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24
K982883	Medtronics Interventional Vascular	MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER	1998-09-04
K132420	Reflow Medical	WINGMAN EXTENDABLE TIP SUPPORT CATHETER	2013-09-19
K082339	Endocross, Ltd.	ENABLER-P SUPPORT CATHETER	2008-11-20
K210009	CenterPoint Systems, LLC	Guiding Catheter	2021-11-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0010-04	Bard Peripheral Vascular	2	Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

Similar Registrations

Registration Number	Establishment Name	Location
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3031768596	PIRAEUS MEDICAL, INC.	Maple Grove, MN, US
3013134719	HEXACATH	Rueil Malmaison Ile-de-France, FR
3011142981	Rontis Hellas S.A.	Larisa Thessalia, GR
3010370269	STRAIT ACCESS TECHNOLOGIES HOLDINGS (PTY) LTD	Cape Town Western Cape, ZA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030236028. Last updated year: 2026. Please use registration number 3030236028 when referencing this establishment in official correspondence.