Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007899424

FEI Number

3007899424

Entity Name

CardioQuip

City/State/Country

College Station, TX, US

Establishment Address

8422 Calibration Ct, College Station, TX 77845, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

CardioQuip LLC (Owner Number: 10044068)

Owner / Operator Contact Address

8422 Calibration Ct, College Station, TX 77845, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K102147

PMA Number

N/A

All Registered Proprietary Names

VC-D-O2E Side Mount Oxygen Tank Holder (type E cylinders) VC-D-SH1 Side Mount Single Hook VC-1000 VivaCart VC-C-INFS Short Infusion Pole with removable hooks VC-A-H04 Compact Handle, 4 cm VC-A-H16 Extended Handle, 16 cm VC-C-INF Infusion Pole Kit VC-D-20A Side Mount Power Strip, 20A VC-A-WP Weight Plate Kit VC-D-SH3 Side Mount Triple Hook VC-C-M46 Corner Mounting Pole, 46 cm VC-E-RTS Removable Upper Shelf VC-E-PGM Pump Guard Mounting Brackets VC-C-M25 Corner Mounting Pole, 25 cm VC-B-VSB Storage Basket MCH Micro MCH-1000 MCH-1000(m) MCH Mini MCH-1000(u) MCH-1000(i) Modular Cooler-Heater

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KRI	Accessory Equipment, Cardiopulmonary Bypass	Cardiovascular	Class 1	870.4200	2023-08-04
DWC	Controller, Temperature, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4250	2013-04-25

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

CardioQuip 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
K001520	Alpha Omega, Inc.	ALPHA OMEGA DUAL COOLER-HEATER	2000-11-22

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2022	CardioQuip, LLC	2	CardioQuip, Modular Cooler-Heater, Model: MCH-1000(i), CE 2797, UDI: (01)00860000846103
Z-0036-2022	CardioQuip, LLC	2	CardioQuip, Modular Cooler-Heater 1000(i), Standard Unit, Model: MCH-10RMS, CE 2797, UDI: (01) 00860000846127
Z-0037-2022	CardioQuip, LLC	2	CardioQuip, Modular Cooler-Heater 1000(m),Compact Unit, Model:MCH-1000(m),CE 2797, UDI: (01)00860000846110
Z-0038-2022	CardioQuip, LLC	2	CardioQuip, Modular Cooler-Heater 1000(m),Thermoelectric Cooling Lid, Model: MCH-11TEC,CE 2797, UDI: (01) 00860000846134

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007899424. Last updated year: 2026. Please use registration number 3007899424 when referencing this establishment in official correspondence.