Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003661577

FEI Number

3003661577

Entity Name

KLUGE DESIGN INC.

City/State/Country

Rogers, MN, US

Establishment Address

14150 Northdale Blvd, Rogers, MN 55374, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Kluge Design LLC (Owner Number: 10030771)

Owner / Operator Contact Address

14150 Northdale Blvd, Rogers, MN 55374, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Affinity CP Adapter Trigger Tome Release System HOLDER 1303 MINIMAX VRB ThoraTrak Model 28603, Blade Long Thoracotomy Standard 16L ThoraTrak Model 28606B, Blade Short Extended Mount Standard 16L ThoraTrak Model, 28604B, Blade Long Extended Mount Standard 16L ThoraTrak Model 28606, Blade Short Thoracotomy Deep 16L KIT THT-JPSTD THORATRAK JP Standard Set ThoraTrak Model 28602, Blade LIMA Deep 16L KIT THT-WWSTD THORATRAK Full System Set ThoraTrak Model 28605, Blade Short Thoracotomy Standard 16L ThoraTrak Model 28604, Blade Long Thoracotomy Deep 16L ThoraTrak Model 28611, Retractor Rack ThoraTrak Model 28601, Blade LIMA Standard 16L ThoraTrak Model 28610, Retractor System Dual Lumen Extended Length Catheter (dELC) VitalFlow Caddy HOLDER MVR-SH 1EA MVR HT2000

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2014-03-10
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2012-12-26
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2012-12-26
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2013-12-17
MPB	Catheter, Hemodialysis, Non-Implanted	Gastroenterology, Urology	Class 2	876.5540	2025-11-20
NQJ	Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use	Gastroenterology, Urology	Class 2	876.5540	2025-11-20
KRI	Accessory Equipment, Cardiopulmonary Bypass	Cardiovascular	Class 1	870.4200	2024-09-03
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2012-12-26
MLW	Warmer, Peritoneal Dialysate	Gastroenterology, Urology	Class 2	876.5630	2024-11-04

Official Correspondent

Erik Kariniemi

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Kluge Design LLC

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K862357	3M Health Care, Sarns	MODIFIED CARDIOTOMY RESERVOIR 5M1470	1986-08-19
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.

Similar Registrations

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2029275	Sterigenics U.S., LLC	Corona, CA, US
3019807891	CENTERPIECE S. DE R.L DE C.V (sterilization site)	Tijuana Baja California, MX
3011554160	Steril Verona srl	Nogara Verona, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003661577. Last updated year: 2026. Please use registration number 3003661577 when referencing this establishment in official correspondence.