FDA Registration
Active
🇺🇸 United States
VASCULAR SOLUTIONS LLC
Reg #: 2134812
·
FEI: 3002827704
·
Expires 2026
Products
28
Proprietary Names
17
Establishment Types
4
Classifications
28
Registration Details
- Registration Name
- VASCULAR SOLUTIONS LLC
- Registration Number
- 2134812
- FEI Number
- 3002827704
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 6464 Sycamore Court North
- City
- Maple Grove
- State
- MN
- ZIP
- 55369
- Country
- US
Regulatory Submissions
- 510(k) Number
- K173891
- PMA Number
- P990037
Owner / Operator
- Firm Name
- Vascular Solutions LLC
- Operator Number
- 9029941
- Address
- 6464 SYCAMORE COURT NORTH, --
- City
- Maple Grove
- State
- MN
- Postal Code
- 55369
- Country
- US
- Correspondent
- Divya Raman
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Catheter | GCB | Class 1 | General, Plastic Surgery | No | 2009-12-01 |
| Device, Vascular, For Promoting Embolization | KRD | Class 2 | Cardiovascular | No | 2018-01-25 |
| Hemostatic Wound Dressing With Thrombin Or Other Biologics | QSX | Class U | Unknown | No | 2020-06-29 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2010-01-11 |
| Anesthesia Conduction Kit | CAZ | Class 2 | Anesthesiology | No | 2022-03-28 |
| Catheter, Percutaneous | DQY | Class 2 | Cardiovascular | No | 2009-01-19 |
| Wire, Guide, Catheter | DQX | Class 2 | Cardiovascular | No | 2017-01-09 |
| Catheter, Intravascular, Diagnostic | DQO | Class 2 | Cardiovascular | No | 2022-06-17 |
| Aspiration Thrombectomy Catheter | QEZ | Class 2 | Cardiovascular | No | 2009-04-23 |
| Electrode, Pacemaker, Temporary | LDF | Class 2 | Cardiovascular | No | 2020-01-16 |
| Device, Percutaneous Retrieval | MMX | Class 2 | Cardiovascular | No | 2017-06-07 |
| Clamp, Vascular | DXC | Class 2 | Cardiovascular | No | 2009-01-22 |
| Catheters, Transluminal Coronary Angioplasty, Percutaneous | LOX | Class 2 | Cardiovascular | No | 2024-06-03 |
| Biopsy Needle | FCG | Class 2 | Gastroenterology, Urology | No | 2021-06-09 |
| Instrument, Biopsy | KNW | Class 2 | Gastroenterology, Urology | No | 2021-06-09 |
| Catheter Introducer Kit | OFC | Class 2 | Cardiovascular | No | 2025-12-10 |
| Agent, Absorbable Hemostatic, Collagen Based | LMF | Class 3 | General, Plastic Surgery | No | 2018-03-14 |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | DTL | Class 2 | Cardiovascular | No | 2012-10-24 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2013-02-20 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2010-05-14 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2010-05-14 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2010-05-14 |
| Device, Hemostasis, Vascular | MGB | Class 3 | Unknown | No | 2007-12-06 |
| Introducer, Catheter | DYB | Class 2 | Cardiovascular | No | 2018-12-12 |
| Orthosis, Limb Brace | IQI | Class 1 | Physical Medicine | No | 2012-06-18 |
| Dressing, Compression | MHW | Class 1 | General Hospital | No | 2002-01-30 |
| Catheter, Continuous Flush | KRA | Class 2 | Cardiovascular | No | 2008-12-22 |
| Catheter, Conduction, Anesthetic | BSO | Class 2 | Anesthesiology | No | 2022-02-15 |
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
TheraCath® Epidural Catheterization Kit
MANTA Vascular Closure Device
FlexTip Plus Combined Spinal Epidural Catheterization Kit
FlexTip Plus Epidural Catheterization Kit
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)