LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS.

K960866 · Lake Region Mfg., Inc. · KNY · Apr 5, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K960866
• Device Name: LRM PRODUCES GUIDEWIRES ON AN OEM BASIS FOR MANUFACTURERS,KIT ASSEMBLERS, AND DISTRIBUTORS.
• Applicant: Lake Region Mfg., Inc.
• Product Code: KNY · Gastroenterology, Urology
• Decision Date: Apr 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 2

Intended Use

The "Intended Use" of the polymer/hydrophilic coated guidewire is to facilitate the placement of catheters or other non-vascular devices during gastroenterology and urology procedures.

Device Story

Polymer/hydrophilic coated guidewires; used to facilitate placement of catheters or non-vascular devices; utilized in gastroenterology and urology procedures; operated by clinicians; provides mechanical guidance for device navigation; benefits patient by enabling accurate, minimally invasive access to target anatomical sites.

Clinical Evidence

Bench testing only.

Technological Characteristics

Polymer/hydrophilic coated spring guidewire; Class II device (21 CFR 876.5130); non-powered mechanical accessory.

Indications for Use

Indicated for patients undergoing gastroenterology and urology procedures requiring the placement of catheters or other non-vascular devices.

Regulatory Classification

Identification

A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

Submission Summary (Full Text)

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510(k) - SUMMARY
K960866

Company Name, Address, and Telephone Number

Lake Region Manufacturing, Inc., (LRM)
340 Lake Hazeltine Drive
Chaska, MN 55318

APR - 5 1996
APR 3 10 10 AM '96

Telephone: [phone]
Fax: [phone]

Device Trade Name/Proprietary Name

LRM produces guidewires on an OEM basis for other manufacturers, kit assemblers, and distributors. Consequently there are a large number of trade and proprietary names not including or associated with LRM. LRM has no proprietary names of its own to be included with this submission.

Device Common Names/Unusual Names, and Classification Names

These devices are commonly known as guides, guidewires, or spring guidewires.

The "Intended Use" of the polymer/hydrophilic coated guidewire is to facilitate the placement of catheters or other non-vascular devices during gastroenterology and urology procedures.

The current classification name is Gastroenterology and Urology Catheter Accessory (78KOD).

LRM Establishment Registration Number: 2126666

Classification of Devices

The classification name listed above was originally classified as a Class II device by the Gastroenterology-Urology Review Panel (21 CFR 876.5130)

Applicability of Performance Standards

LRM has determined that no mandatory performance standards have been established for these devices under Section 514 of the Medical Device Amendments to Federal Food, Drug, and Cosmetic Act or by any subsequent regulatory action. LRM has also determined that there are no applicable voluntary standards.

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