Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001374820

FEI Number

3001374820

Entity Name

SURMODICS, INC.

City/State/Country

EDEN PRAIRIE, MN, US

Establishment Address

9924 W 74th St, EDEN PRAIRIE, MN 55344, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

SURMODICS, INC. (Owner Number: 9070604)

Owner / Operator Contact Address

9924 WEST 74TH STREET, --, Eden Prairie, MN 55344, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K173560

PMA Number

N/A

All Registered Proprietary Names

SurVeil Drug-Coated Balloon

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ONU	Drug-Eluting Peripheral Transluminal Angioplasty Catheter	Unknown	Class 3	N/A	2023-08-09
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2018-03-29

Official Correspondent

CARLA ERICKSON

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SURMODICS, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014687026	SURMODICS, INC.	Eden Prairie, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
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
K082339	Endocross, Ltd.	ENABLER-P SUPPORT CATHETER	2008-11-20
K210009	CenterPoint Systems, LLC	Guiding Catheter	2021-11-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0010-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001374820. Last updated year: 2026. Please use registration number 3001374820 when referencing this establishment in official correspondence.