Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1318694

FEI Number

1318694

Entity Name

NUMED, INC.

City/State/Country

Hopkinton, NY, US

Establishment Address

2880 MAIN ST., Hopkinton, NY 12965, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

NUMED, INC. (Owner Number: 1318694)

Owner / Operator Contact Address

2880 MAIN ST., --, Hopkinton, NY 12965, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K160598

PMA Number

N/A

All Registered Proprietary Names

PTS-X Tyshak II & Z-MED II BIB Stent Placement Catheter NuCLEUS-X BIB Stent Placement Catheter Multi-Track X-line Catheters COEfficient D'Vill Covered Mounted CP Stent CP Stent Mounted CP Stent Covered CP Stent NuDEL G-Armor Stent G-Armor Mounted Stent G-Armor Covered Mounted Stent G-Armor Covered Stent Ghost, Tyshak & Z-MED Z-MED II Z-MED PTS Tyshak & Z-MED Z-6 Atrioseptostomy Catheter Z-MED Bonhoeffer Mitral Valve Kit NuCLEUS NuCLEUS-X Ensemble II Transcatheter Valve Delivery System Tyshak II & Z-MED II MINI GHOST CATHETER BIB Atrioseptostomy BIB CATHETER Mullins-X REBOA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2007-10-09
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2007-10-09
NVM	Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon	Cardiovascular	Class 2	870.1250	2016-09-22
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2008-07-18
NVM	Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon	Cardiovascular	Class 2	870.1250	2016-07-27
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2007-10-09
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2007-10-09
OMZ	Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter	Cardiovascular	Class 2	870.1250	2007-10-09
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2017-10-23
PNF	Aortic Stent	Unknown	Class 3	N/A	2016-03-28
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2007-10-09
OZT	Balloon Aortic Valvuloplasty	Cardiovascular	Class 2	870.1255	2012-10-10
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2007-10-09
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2007-10-09
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2007-10-09
DXF	Catheter, Septostomy	Cardiovascular	Class 2	870.5175	2021-07-20
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2007-10-09
MAD	Catheter, Percutaneous (Valvuloplasty)	Unknown	Class 3	N/A	2008-09-04
OZT	Balloon Aortic Valvuloplasty	Cardiovascular	Class 2	870.1255	2012-10-10
NPV	Pulmonary Valve Prosthesis Percutaneously Delivered	Unknown	Class f	N/A	2015-02-13
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Cardiovascular	Class 2	870.1250	2007-10-09
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	1992-07-07
NVM	Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon	Cardiovascular	Class 2	870.1250	2021-06-09
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2007-10-09
NVM	Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon	Cardiovascular	Class 2	870.1250	2006-05-24
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2007-10-09
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2016-09-15

Official Correspondent

NICHELLE LAFLESH

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

NUMED, 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
K051067	LeMaitre Vascular, Inc.	PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)	2005-05-27
K093847	Thermopeutix, Inc.	DUFLO CATHETER (HEPARIN COATED)	2010-08-25
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24
K982883	Medtronics Interventional Vascular	MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER	1998-09-04
K132420	Reflow Medical	WINGMAN EXTENDABLE TIP SUPPORT CATHETER	2013-09-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2009	Edwards Lifesciences, LLC	2	Edwards Lifesciences*Fogarty Fortis*Arterial Embolectomy Catheter Is indicated for the removal of fresh, soft emboli and thrombi from the vessels in the arterial system.
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04	Bard Peripheral Vascular	2	Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1318694. Last updated year: 2026. Please use registration number 1318694 when referencing this establishment in official correspondence.