Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2134812

FEI Number

3002827704

Entity Name

VASCULAR SOLUTIONS LLC

City/State/Country

Maple Grove, MN, US

Establishment Address

6464 Sycamore Court North, Maple Grove, MN 55369, 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

K151234

PMA Number

N/A

All Registered Proprietary Names

Drainer Centesis Catheter FlexBlock® Continuous Peripheral Nerve Block Kit D-Stat Flowable Hemostat D-Stat Dry topical hemostat Ringer perfusion balloon catheter StimuCath® Continuous Peripheral Nerve Block Kit VSI Micro-Introducer Kit Pronto V4 Extraction Catheter VSI Torque Device AngioAssist docking station Teirstein Edge device organizer Accumed II Wrist Positioning Splint Accumed LP Wrist Positioning Splint

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCB	Needle, Catheter	General, Plastic Surgery	Class 1	878.4200	2009-12-01
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2018-01-25
QSX	Hemostatic Wound Dressing With Thrombin Or Other Biologics	Unknown	Class U	N/A	2020-06-29
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2010-01-11
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2022-03-28
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2010-01-07
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2023-01-30
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2009-01-19
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2017-01-09
QSX	Hemostatic Wound Dressing With Thrombin Or Other Biologics	Unknown	Class U	N/A	2007-12-06
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2022-06-17
QSX	Hemostatic Wound Dressing With Thrombin Or Other Biologics	Unknown	Class U	N/A	2007-12-06
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2009-04-23
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2018-02-20
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2020-01-16
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2020-01-16
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2017-02-03
MMX	Device, Percutaneous Retrieval	Cardiovascular	Class 2	870.5150	2017-06-07
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2009-01-22
QSX	Hemostatic Wound Dressing With Thrombin Or Other Biologics	Unknown	Class U	N/A	2009-01-22
QSX	Hemostatic Wound Dressing With Thrombin Or Other Biologics	Unknown	Class U	N/A	2011-05-11
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2024-06-03
QSX	Hemostatic Wound Dressing With Thrombin Or Other Biologics	Unknown	Class U	N/A	2009-09-15
CAZ	Anesthesia Conduction Kit	Anesthesiology	Class 2	868.5140	2022-03-28
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2012-11-29
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2021-06-09
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2021-06-09
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2009-09-15
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2018-01-05
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2018-08-17
OFC	Catheter Introducer Kit	Cardiovascular	Class 2	870.1340	2025-12-10
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2009-01-22
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2018-01-08
LMF	Agent, Absorbable Hemostatic, Collagen Based	General, Plastic Surgery	Class 3	878.4490	2018-03-14
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2014-11-25
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2012-10-24
QEZ	Aspiration Thrombectomy Catheter	Cardiovascular	Class 2	870.5150	2011-01-04
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2021-06-09
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2010-05-03
QSX	Hemostatic Wound Dressing With Thrombin Or Other Biologics	Unknown	Class U	N/A	2009-01-22
FTY	Tape, Measuring, Rulers And Calipers	General, Plastic Surgery	Class 1	878.4800	2013-02-20
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2018-06-21
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2009-10-16
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2010-11-16
QSX	Hemostatic Wound Dressing With Thrombin Or Other Biologics	Unknown	Class U	N/A	2008-12-30
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2010-05-14
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2010-05-14
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2010-05-14
MGB	Device, Hemostasis, Vascular	Unknown	Class 3	N/A	2007-12-06
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2018-12-12
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2007-12-06
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2020-11-13
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2021-07-14
FCG	Biopsy Needle	Gastroenterology, Urology	Class 2	876.1075	2021-06-09
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2021-06-09
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2023-06-07
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2023-06-07
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2019-12-16
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2011-11-08
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2012-06-18
GEX	Powered Laser Surgical Instrument	General, Plastic Surgery	Class 2	878.4810	2009-06-24
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2018-06-21
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2015-11-19

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
3030236028	Teleflex LLC	Brooklyn Park, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K083258	Dornier Medtech America, Inc.	MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE	2009-01-30
K201111	Candela Corporation	GentleMax Pro Plus	2020-05-26
K202758	Shangdong Huamei Technology Co., Ltd.	Nd: YAG Laser Therapy Systems HM-YL900	2020-11-16
K904068	Luxar Corp.	LUXAR MODEL LX-20 CO2 LASER	1991-04-15
K142225	CAO Group, Inc.	Pilot Elite Diode Laser	2014-09-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2014	PhotoMedex, Inc.	2	The product is labeled in part "*Surgical Laser Technologies, Inc. Montgomeryville, PASLT Fiber Delivery SystemSterileNon-Pyrogenic**. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018	Medtronic Navigation, Inc.	2	VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007	Lumenis Inc.	2	Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2134812. Last updated year: 2026. Please use registration number 2134812 when referencing this establishment in official correspondence.