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Sign in to claim this brandLake Region Medical
United States·US-MF-000033013
Last updated September 17, 2026
About
We provide innovative, high quality medical device technologies - including catheters, guidewires, introducers, delivery systems, tantalum capacitors, implantable ports, neuromodulation devices, pacemaker batteries, implantable and external batteries, and much more – to meet customers’ needs and help enhance the lives of patients worldwide. The products we design and manufacture range from finished device systems to Class III Medical Devices and hundreds of components dispersed among more than 15 markets. We also provide market-ready products to medical device OEMs. From product design to completed systems, our expertise in medical device development and battery design is foundational to the history of cardiac rhythm and cardio and vascular health.
From the manufacturer's own website. Source
What Lake Region Medical makes
Lake Region Medical makes guidewires, including peripheral vascular, gastro-urological, and cardiac/peripheral vascular guidewires, as well as endomyocardial biopsy forceps. Their products include examples such as Forté, M-Wire Hydrophilic Coated, and ZIPwire guidewires.
The company's portfolio is regulated under Class I and Class II devices and is listed in the FDA 510k and FDA UDI registries. Lake Region Medical is based in the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What type of devices does Lake Region Medical make?
Lake Region Medical makes guidewires, including peripheral vascular, gastro-urological, and cardiac/peripheral vascular guidewires, as well as endomyocardial biopsy forceps, to meet various medical needs.
Where is Lake Region Medical based?
Lake Region Medical is based in the US, indicating its primary location for operations and manufacturing.
Which registries list Lake Region Medical's devices?
Lake Region Medical's devices are listed in the FDA 510k and FDA UDI registries, which track and regulate medical devices in the US.
How are Lake Region Medical's devices classified?
The company's devices are classified under Class I and Class II, which determines the level of regulatory control and oversight for each device type.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 340, Lake Hazeltine Drive, Chaska, United States
- Website
- www.integer.net
- —
- —
- [email protected]
- Phone
- 952-448-5111
- PRRC Contact
- Deko Hussein
- EUDAMED SRN
- US-MF-000033013
- FDA FEI Number
- 2126666
- DUNS Number
- —
Catalogue (235)
Page 5 of 5| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Paragon | LR1BF034V | FDA UDI | Class II | Active |
| Starter™ Guidewire | M001491101 | FDA UDI | Class II | Active |
| Forté™ | H7493494909J0 | FDA UDI | Class II | Active |
| ZIPwire™ | M00146316B0 | FDA UDI | Class II | Active |
| Starter™ Guidewire | M001491011 | FDA UDI | Class II | Active |
| ZIPwire™ | M006630213B0 | FDA UDI | Class I | Active |
| PTFE Coated Urological Guidewire | M0066201250 | FDA UDI | Class I | Active |
| Starter™ Guidewire | M001491191 | FDA UDI | Class II | Active |
| Starter™ Guidewire | M001491031 | FDA UDI | Class II | Active |
| PTFE Coated Urological Guidewire | M0066201200 | FDA UDI | Class I | Active |
| ZIPwire™ | M006630202B0 | FDA UDI | Class I | Active |
| Starter™ Guidewire | M001492311 | FDA UDI | Class II | Active |
| Safari2™ | H74939706JPNS0 | FDA UDI | Class II | Unknown |
| Thruway™ | M001492791 | FDA UDI | Class II | Active |
| Safari™ | H74939272S0 | FDA UDI | Class II | Active |
| Starter™ Guidewire | M001491221 | FDA UDI | Class II | Active |
| Starter™ Guidewire | M001492271 | FDA UDI | Class II | Active |
| Starter™ Guidewire | M001491571 | FDA UDI | Class II | Active |
| Thruway™ | M001492821 | FDA UDI | Class II | Active |
| Paragon | LR1BF030V | FDA UDI | Class II | Active |
| Ostavi Hydrophilic Guidewire | K124052 | FDA 510(k) | Class II | Active |
| Anchorwire Guidewire | K111288 | FDA 510(k) | Class II | Active |
| Mandrel Guidewires Or M-Wire | K080508 | FDA 510(k) | Class II | Active |
| Pre-Formed Guidewires | K130798 | FDA 510(k) | Class II | Active |
| ENROUTE 0.014 Guidewire | K160643 | FDA 510(k) | Class II | Active |
| Predicate Iii Guidewire | K142393 | FDA 510(k) | Class II | Active |
| Enroute 0.014'' Transcarotid Guidewire | K253746 | FDA 510(k) | Class II | Active |
| Mandrel Guidewire | K140485 | FDA 510(k) | Class II | Active |
| Mandrel Guidewire | K140482 | FDA 510(k) | Class II | Active |
| Pre-Formed Blue | K221575 | FDA 510(k) | Class II | Active |
| Hi Torque Connect Guidewire | K112381 | FDA 510(k) | Class II | Active |
| Predicate III Guidewire | K142397 | FDA 510(k) | Class II | Active |
| Hydrophilic Coated Guidewire | K133155 | FDA 510(k) | Class II | Active |
| Pre-Formed Extra Support Guidewire | K211741 | FDA 510(k) | Class II | Active |
| Pre-Formed Guidewire | K151244 | FDA 510(k) | Class II | Active |
| Hi Torque Connect Guidewire, Hi Torque Connect Flex Guidewire, Hi Torque Connect 250t Guidewire | K140536 | FDA 510(k) | Class II | Active |
| PTFE Guidewire | K242824 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Lake Region Medical Limited NEW ROSS Wexford · IE FEI 3002807439