Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1927395

FEI Number

1927395

Entity Name

POLO CUSTOM PRODUCTS

City/State/Country

MONTICELLO, IA, US

Establishment Address

902 NORTH BIRCH RD., MONTICELLO, IA 52310, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Polo Custom Products (Owner Number: 9919026)

Owner / Operator Contact Address

3601 SW 29th Street, --, Topeka, KS 66614, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2023-12-04
MVK	Wearable Automated External Defibrillator	Unknown	Class 3	N/A	2021-08-18
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2025-02-05
DSQ	Ventricular (Assist) Bypass	Unknown	Class 3	N/A	2025-01-10

Official Correspondent

Dawn Silver

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Polo Custom Products

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3016704581	POLO CUSTOM PRODUCTS	Louisville, MS, US

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2007	Thoratec Corp	3	Thoratec brand TLC-II Portable Ventricular Assist Device (VAD) Driver; Catalog No. 20010-2085-000 Distributed and Manufactured by Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588
Z-0005-2017	Heartware, Inc.	3	HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter
Z-0006-2017	HeartWare, Inc	3	HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Z-0015-2007	Thoratec Corp	3	Thoratec brand Sealed Arterial Cannula for use with the Thoratec Vascular Assist Device System, Model Number(s): Catalogue numbers: #100118-- Short, 14mm graft; #100121-- Long, 14mm graft; #100129-- Long, 18mm graft. Manufactured by Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588

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3005809810	Jarit GmbH	Rietheim-Weilheim Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1927395. Last updated year: 2026. Please use registration number 1927395 when referencing this establishment in official correspondence.