Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2032677

FEI Number

3003945344

Entity Name

INSIGHTRA MEDICAL, INC.

City/State/Country

Clarksville, TN, US

Establishment Address

2543 Madison St, Unit 105, Clarksville, TN 37043, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

INSIGHTRA MEDICAL, INC. (Owner Number: 9054804)

Owner / Operator Contact Address

2543 Madison St., #105, Clarksville, TN 37043, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Catheter Retractor Hemostasis Y Connector Kit Ultra IABP 7FR Cathether Kit INSTRUMENT, MANUAL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGZ	Accessories, Catheter	General, Plastic Surgery	Class 1	878.4200	2003-04-10
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2007-08-24
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2023-10-30
DSP	System, Balloon, Intra-Aortic And Control	Cardiovascular	Class 2	870.3535	2009-02-18
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2009-12-12

Official Correspondent

Sandie Hetland

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

INSIGHTRA MEDICAL, INC.

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
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
K915301	Advance Medical Designs, Inc.	ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK	1992-12-11
K903893	Datascope Corp.	DATASCOPE PERCOR STAT 9.5 FR 40CC INTRA-AORTIC BAL	1990-10-19

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

Registration Number	Establishment Name	Location
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3032028815	KAHLO SCIENCES, LLC	Cambridge, MA, US
8031007	B. BRAUN MEDICAL AG	ESCHOLZMATT Luzern, CH
3005334138	St. Jude Medical, Cardiology Division, Inc.	Plymouth, MN, US
3020460367	BOUND TREE MEDICAL, LLC	Grand Prairie, TX, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2032677. Last updated year: 2026. Please use registration number 2032677 when referencing this establishment in official correspondence.