STERILMED, INC.

FDA Device Registration & Listing · Plymouth, MN, US · Registration 3011276773

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3011276773
FEI Number
3011276773
Entity Name
STERILMED, INC.
City/State/Country
Plymouth, MN, US
Establishment Address
5010 Cheshire Pkwy N Ste 2, Plymouth, MN 55446, US
Establishment Type(s)
Reprocess Single-Use Device,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
STERILMED, INC. (Owner Number: 9030419)
Owner / Operator Contact Address
5010 Cheshire Parkway N, Suite 2, Plymouth, MN 55446, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K051220
PMA Number
N/A

All Registered Proprietary Names

Reprocessed Ultrasound Catheter Reprocessed Imaging Catheter Reprocessed Lasso Nav eco and Reprocessed Lasso 2515 Nav eco Variable Electrophysiology (EP) Catheters Reprocessed EP Catheters Reprocessed EP Catheters Reprocessed EP Catheter Reprocessed EP Catheter Reprocessed EP Catheters Reprocessed DECANAV Electrophysiology Catheter EP Catheter Reprocessed External Fixation Device MAXFRAME Reprocessed External Fixation Device Reprocessed EP Catheter

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OWQ Reprocessed Intravascular Ultrasound Catheter Cardiovascular Class 2 870.1200 2011-11-15
OWQ Reprocessed Intravascular Ultrasound Catheter Cardiovascular Class 2 870.1200 2015-11-11
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2016-06-23
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2003-07-01
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2012-10-30
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2015-11-11
NLG Catheter, Intracardiac Mapping, High-Density, Reprocessed Cardiovascular Class 2 870.1220 2021-08-13
MTD Catheter, Intracardiac Mapping, High-Density Array Cardiovascular Class 2 870.1220 2021-08-13
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2015-11-11
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2010-10-20
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2024-10-30
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording Cardiovascular Class 2 870.1220 2024-10-30
QNW Reprocessed Bronchoscope Ear, Nose, Throat Class 2 874.4680 2024-01-04
OWQ Reprocessed Intravascular Ultrasound Catheter Cardiovascular Class 2 870.1200 2019-11-18
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2015-11-11
QNW Reprocessed Bronchoscope Ear, Nose, Throat Class 2 874.4680 2021-05-06
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2009-10-26
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2019-10-28
OSN Software For Diagnosis/Treatment Orthopedic Class 2 888.3030 2019-10-28
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2015-09-11
NLH Catheter, Recording, Electrode, Reprocessed Cardiovascular Class 2 870.1220 2015-11-11

Official Correspondent

Robert Macnamara

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

STERILMED, 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
K232130 Surgical Instrument Services and Savings, Inc. Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter 2023-12-15
K230934 ABBOTT MEDICAL ViewFlex™ Eco Reprocessed ICE Catheter 2023-05-03
K150357 Sterilmed, Inc. Reprocessed Electrophysiology Diagnostic Catheters 2015-08-27
K043393 Alliance Medical Corp. REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS 2005-03-23
K241372 ABBOTT MEDICAL Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ 2024-07-09

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011276773. Last updated year: 2026. Please use registration number 3011276773 when referencing this establishment in official correspondence.
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