Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003955307

FEI Number

3003955307

Entity Name

Medtronic Grand Rapids

City/State/Country

Grand Rapids, MI, US

Establishment Address

620 Watson SW, Grand Rapids, MI 49504, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Medtronic, Inc. (Owner Number: 2112641)

Owner / Operator Contact Address

710 Medtronic Parkway, Minneapolis, MN 55432, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K121451

PMA Number

N/A

All Registered Proprietary Names

DLP Cannula EGM Cable Cardioblate MAPS Cardioblate Surgical Ablation Pen Cardioblate XL Surg Abl Pen Cardioblate Surg Abl System ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES DLP Silicone Coronary Artery Ostial Cannulae OVAL MC2Two-Stage Venous Cannula Thin Wall Two-Stage Venous Cannula MC2Two-Stage Venous Cannula MC2XThree-Stage Venous Cannula DLP Rapid Prime Set, 14 DLP Cannula DLP Air Aspirating Needle DLP Aortic Root Cannula MC2X Three-Stage Venous Cannula MC2 Two-Stage Venous Cannula DLP Tourniquet Set, Pediatric EOPA 3D Arterial Cannula DLP Cannula CLAMP, SURGICAL, GENERAL & PLASTIC SURGERY Carpentier Bi-Caval Femoral Cannula Gauge, Pressure, Coronary, Cardiopulmonary Bypass Bio-Medicus Cannula DLP Coronary Artery Ostial Cannula CATHETER, CANNULA &TUBING, VASCULAR, CARDIOPULMONARY BYPASS Select 3D Adaptors Quickflow DPS Vacuum Relief Valve Distal Perfusion Kit Connectors Bio-Medicus Cannula Cardiopulmonary bypass vascular catheter, cannula, or tubing EOPA Signature DLP Cannula Cannula Vent Catheter DLP Suction Tube DLP Silicone Coronary Artery Ostial Cannulae Clearview DLP Cannula Gundry RSCP DLP PVC RCSP Cannulae Auto-Inflate Cuff, 12 in. (30.5 cm) length - Smooth preformed Cuff, short fluted, bullet nosed DLP Silicone RCSP Cannulae Auto-Inflate Cuff 12.5in. (31.8 cm) length- WW Body/Smooth preformed Cuff -guidewire Stylet/ DLP PVC RCSP Cannulae Auto-Inflate Cuff, 10 in. (25.4 cm) length - Smooth preformed Cuff, short fluted tip, and integ DLP PVC RCSP Cannulae Auto-Inflate Cuff 11 in. (27.9 cm) length - Smooth preformed Cuff, Multi-port tip, and integral DLP PVC RCSP Cannulae Auto-Inflate Cuff, 12.5 in. (31.8cm) length - Ridged preformed Silicone Cuff, short fluted, bulle DLP Silicone RCSP Cannulae Auto-Inflate Cuff 12.5in. (31.8 cm) length-WW Body/Smooth preformed Cuff -Solid Stylet/Tru-T DLP PVC RCSP Cannulae Auto-Inflate Cuff, 12.5 in. (31.8 cm) length - Smooth preformed Cuff, fluted, bullet nosed tip, a DLP Silicone RCSP Cannulae Auto-Inflate Cuff 12.5in. (31.8 cm) length - WW Body/Smooth preformed Cuff - Solid Stylet DLP Silicone RCSP Cannulae Auto-Inflate Cuff 12.5in. (31.8 cm) length- WW Body/Ridged preformed Cuff- Solid Stylet/Tru- DLP Silicone RCSP Cannulae Auto-Inflate Cuff 12.5in. (31.8 cm) length - WW Body/Smooth preformed Cuff - Guidewire Sty DLP Silicone RCSP Cannulae Auto-Inflate Cuff 12.5in. (31.8 cm) - WW Body/Ridged preformed Cuff- guidewire Stylet/Tru-To DLP PVC RCSP Cannulae Auto-Inflate Cuff 11 in. (27.9 cm) length - Smooth preformed Cuff, multi-port tip, and integral DLP PVC RCSP Cannulae Auto-Inflate Cuff, 12.5 in. (31.8 cm) length -Ridged preformed Silicone Cuff, short fluted, bulle DLP PVC RCSP Cannulae Auto-Inflate Cuff, 12.5 in. (31.8 cm) length - Ridged preformed Silicone Cuff, short fluted, bull DLP PVC RCSP Cannulae Auto-Inflate Cuff, 12.5 in. (31.8 cm) length - Smooth preformed Cuff, fluted, bullet nosed tip, DLP Pericardial Sump DLP Cannula RCSP Cannula ClearView Intracoronary Shunts Cardioblate 49313 Surgical Ablation Pen Cardioblate 49314 XL Surgical Ablation Pen Cannula Urchin Starfish Octopus MITRAL COLLAR AND TIE Actuators Rotation Tool Kit AORTIC CUFF Universal Mounting Rail pinch on tool MEDIUM BLADE SET TOOL Lead Accessory Kit Adjustable Slitter Implant Tool Kit ATRIAL LIFT SYSTEM Accessory Port ATS Medical Thoracic Port System EXTRA LG BLADE SET TOOL INTERCOSTAL RETRACTOR SYSTEM SUTURE BELT LARGE BLADE SET TOOL STERILIZATION TRAY TOOL RETRACTOR RACK TOOL SMALL BLADE SET TOOL Mounting Rail Universal II Slitter ABLATION PEN 4920501 W/PACING

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2008-03-14
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2014-02-07
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2024-09-23
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2014-05-27
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2008-03-14
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2013-08-21
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2013-08-21
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2025-08-21
HAM	Apparatus, Electrosurgical	General, Plastic Surgery	Class 2	878.4400	2008-03-14
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2015-04-22
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2008-03-14
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2014-05-27
DXS	Gauge, Pressure, Coronary, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4310	2018-08-16
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2013-11-08
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2012-06-25
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2017-10-05
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2008-03-14
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2014-09-08
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2014-01-28
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2011-01-27
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
DRA	Catheter, Steerable	Cardiovascular	Class 2	870.1280	2008-03-14
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2008-03-14
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2024-09-23
FQH	Lavage, Jet	General Hospital	Class 2	880.5475	2008-03-14
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2015-01-09
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2013-05-02
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2026-01-22
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2019-07-03
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2008-03-14
MWS	Stabilizer, Heart	Cardiovascular	Class 1	870.4500	2008-03-14
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	1992-12-02
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2013-11-12
OCL	Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue	General, Plastic Surgery	Class 2	878.4400	2013-11-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medtronic, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

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3007042319	HeartWare, Inc.	Miami Lakes, FL, US
3004497303	MEDTRONIC MEXICO EG	EMPALME Sonora, MX
3015192387	CATHWORKS	Newport Beach, CA, US
3004185781	Medtronic, Inc.	Tempe, AZ, US
3012520654	MEDTRONIC, INC.	Billerica, MA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K103464	Medtronic, Inc.	PACIFIC XTREME PTCA BALLOON DILATATION CATHETER	2010-12-22
K111339	Medtronic, Inc.	HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)	2011-06-08
K832124	Med-West, Inc.	CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI	1983-08-12
K162500	Spyder Medical	Ostial Sprit Cannulae	2017-01-12
K120857	Ncontact Surgical, Inc.	EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX	2012-11-13

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-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0001-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 1500mL, (legless) REF 66615 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.
Z-0002-2020	The Metrix Company	2	SECURE EVA - DUAL CHAMBER CONTAINER With Screw Connectors, 3000mL, (legless) REF 66630 - Product Usage: For use in an intravenous admixture program. The empty container will be filled with parenteral admixtures under normal pharmacy conditions, e.g. laminar flow hood. The use of this product is for storage and delivery of intravenous parenteral admixtures.

Similar Registrations

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3038776570	INVOSURG INC	Canton, MA, US
3009380063	Medtronic Distribution Center	Memphis, TN, US
2916596	THORATEC CORP.	PLEASANTON, CA, US
1836324	Rose Medical	Grand Rapids, MI, US
3019807891	CENTERPIECE S. DE R.L DE C.V (sterilization site)	Tijuana Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003955307. Last updated year: 2026. Please use registration number 3003955307 when referencing this establishment in official correspondence.