Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017540705

FEI Number

3017540705

Entity Name

MED MICHIGAN HOLDINGS LLC

City/State/Country

Lake Odessa, MI, US

Establishment Address

1017 4th Ave, Lake Odessa, MI 48849, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MED Michigan Holdings LLC (Owner Number: 10078584)

Owner / Operator Contact Address

1017 4th Ave, Lake Odessa, MI 48849, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K971022

PMA Number

N/A

All Registered Proprietary Names

Blowmister Retrograde Cardioplegia Cannula (Manual Inflate) - 15 Fr, Rigid Stylet, Smooth Balloon Retrograde Cardioplegia Cannula (Manual Inflate) - 15 Fr, No Stylet, Textured Balloon, Stopcock Retrograde Cardioplegia Cannula (Manual Inflate) - 15 Fr, Sure Touch® Handle, Textured Balloon, Stopcock Retrograde Cardioplegia Cannula (Manual Inflate) - 15 Fr, Guidewire Stylet, Smooth Balloon Retrograde Cardioplegia Cannula (Manual Inflate) - 15 Fr, Rigid Stylet, Textured Balloon, Stopcock Retrograde Cardioplegia Cannula (Manual Inflate) - 15 Fr, Guidewire Stylet, Textured Balloon, Stopcock Retrograde Cardioplegia Cannula (Manual Inflate) - 15 Fr, Rigid Stylet, Smooth Balloon, Stopcock Retrograde Cardioplegia Cannula (Manual Inflate) - 15 Fr, Sure Touch® Handle, Smooth Balloon Retrograde Cardioplegia Cannula (Manual Inflate) - 15 Fr, Guidewire Stylet, Smooth Balloon, Stopcock Retrograde Cardioplegia Cannula (Manual Inflate) - 15 Fr, Sure Touch® Handle, Smooth Balloon, Stopcock Retrograde Cardioplegia Cannula (Self Inflate) -15 Fr, Guidewire Stylet, Smooth Balloon Retrograde Cardioplegia Cannula (Self Inflate) - 15 Fr, Rigid Stylet, Smooth Balloon Retrograde Cardioplegia Cannula (Self Inflate) - 15 Fr, Sure Touch® Handle, Textured Balloon Retrograde Cardioplegia Cannula (Self Inflate) - 15 Fr, Rigid Stylet, Textured Balloon Retrograde Cardioplegia Cannula (Selfl Inflate) - 15 Fr, No Stylet, Smooth Balloon Retrograde Cardioplegia Cannula (Self Inflate) - 15 Fr, Sure Touch® Handle, Smooth Balloon Retrograde Cardioplegia Cannula (Self Inflate) -15 Fr, Guidewire Stylet, Textured Balloon Suction Safety Device Adult Tourniquet Kit with Snare Vena Caval Tourniquet Kit with Snare Pediatric Tourniquet Kit with Snare Complete Adult Tourniquet Kit with Snare Custom Tourniquet Kit with Snare Perfusion Set, Y-Type with Vent Perfusion Set, Straight Perfusion Set, Recirculating Multiple Perfusion Set with Vent Multiple Perfusion Set Perfusion Set, Y-Type Vessel Cannula with Guyton Soft Tip Internal Coronary Vessel Cannula Perfusion Cannula Saphenous Vein Cannula Vessel Cannula Direct Suction Adaptor Peak Left Ventricular Vent Cannula (16Fr) Peak Left Ventricular Vent Cannula (18Fr) Peak Left Ventricular Vent Cannula (20Fr) Myocardial Temperature Probe (15mm) Myocardial Temperature Probe (18mm) Myocardial Temperature Probe (44mm) Myocardial Temperature Probe (30mm) Rigid Intracardiac Sucker Flexible Intracardiac Sucker Rigid Mini Intracardiac Sucker

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2020-10-28
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2020-10-28
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2020-10-28
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2020-10-28
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2020-10-28
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2020-10-28
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2020-10-28
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2020-10-28
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2020-10-28
KRI	Accessory Equipment, Cardiopulmonary Bypass	Cardiovascular	Class 1	870.4200	2020-10-28
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2020-10-28

Official Correspondent

James Wisniewski

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MED Michigan Holdings 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
K213616	Becton, Dickinson and Company	BD Surgiphor Antimicrobial Irrigation System	2022-03-23
K832124	Med-West, Inc.	CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI	1983-08-12
K162500	Spyder Medical	Ostial Sprit Cannulae	2017-01-12
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2022	Medtronic Perfusion Systems	2	Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Z-0021-2018	OriGen Biomedical, Inc.	2	The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017540705. Last updated year: 2026. Please use registration number 3017540705 when referencing this establishment in official correspondence.