OSCOR INC.

FDA Device Registration & Listing · PALM HARBOR, FL, US · Registration 1035166

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
1035166
FEI Number
1035166
Entity Name
OSCOR INC.
City/State/Country
PALM HARBOR, FL, US
Establishment Address
4875 Palm Harbor Blvd, PALM HARBOR, FL 34683, US
Establishment Type(s)
Sterilize Medical Device for Another Party (Contract Sterilizer),Repack or Relabel Medical Device
Owner / Operator
OSCOR INC. (Owner Number: 1035166)
Owner / Operator Contact Address
4875 Palm Harbor Blvd, --, Palm Harbor, FL 34683, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
P150009

All Registered Proprietary Names

Freedom-4 Stimulator ATAR Medtronic (ATAR OEM Brands) 53912D Medtronic (ATAR OEM Brands) 53912A Medtronic (ATAR OEM Brands) 53912 EMBSNV20 BSNV-8 Extension Adaptor kit LEAD ADAPTORS Adelante Adelante-S, SafeSheath Ultra with VBT VS-1 DiREX Adelante Destino Vein Picks TEMPORARY PACING PRODUCTS Adelante Radial Angios Arrive Adelante Breezeway Delivery Sheath Vein Pick Vein Pick Breezeway II ELECTRODE, PACEMAKER, TEMPORARY TEMPORARY PACING PRODUCTS TB HELIOS LEAD ADAPTORS AND EXTENSIONS Adelante-S Lite, Adelante-S2, Adelante-S-RS, Adelante SII, SafeSheath II Adelante - S Series VS-32 MC-526 MC-01 Adelante Magnum Destino Reach TEMPORARY PACING PRODUCTS LEAD ADAPTORS AND EXTENSIONS TEMPORARY PACING PRODUCTS TME 65 TME 64 Port Plug IS4/DF4 Port Plug Angel Medical repack of generator, pack and sterilize torque wrench

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GZB Stimulator, Spinal-Cord, Implanted (Pain Relief) Neurology Class 2 882.5880 2015-03-27
IKD Cable, Electrode Physical Medicine Class 2 890.1175 2007-08-14
LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief Unknown Class 3 N/A 2022-05-23
DTD Pacemaker Lead Adaptor Cardiovascular Class 2 870.3620 1992-07-06
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2008-03-05
DTB Permanent Pacemaker Electrode Cardiovascular Class 3 870.3680 2013-11-19
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2012-09-10
DTB Permanent Pacemaker Electrode Cardiovascular Class 3 870.3680 1992-07-06
LDF Electrode, Pacemaker, Temporary Cardiovascular Class 2 870.3680 1992-07-06
DTB Permanent Pacemaker Electrode Cardiovascular Class 3 870.3680 2014-05-19
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2014-03-07
DQO Catheter, Intravascular, Diagnostic Cardiovascular Class 2 870.1200 2010-03-06
QLK Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief Unknown Class 3 N/A 2025-07-01
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2010-11-17
DTB Permanent Pacemaker Electrode Cardiovascular Class 3 870.3680 1992-07-06
DTB Permanent Pacemaker Electrode Cardiovascular Class 3 870.3680 1992-07-06
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2021-08-26
LDF Electrode, Pacemaker, Temporary Cardiovascular Class 2 870.3680 1992-07-06
QJP Catheter, Percutaneous, Neurovasculature Cardiovascular Class 2 870.1250 2023-04-24
LDF Electrode, Pacemaker, Temporary Cardiovascular Class 2 870.3680 2008-03-05
DTD Pacemaker Lead Adaptor Cardiovascular Class 2 870.3620 1992-07-06
PSR Implanted Phrenic Nerve Stimulator For Central Sleep Apnea Unknown Class 3 N/A 2017-10-18
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2012-09-10
DTB Permanent Pacemaker Electrode Cardiovascular Class 3 870.3680 2013-11-19
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2014-08-07
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2015-12-08
LDF Electrode, Pacemaker, Temporary Cardiovascular Class 2 870.3680 1992-07-06
DTD Pacemaker Lead Adaptor Cardiovascular Class 2 870.3620 1992-07-06
LDF Electrode, Pacemaker, Temporary Cardiovascular Class 2 870.3680 1992-07-06
DTD Pacemaker Lead Adaptor Cardiovascular Class 2 870.3620 2015-03-27
DYB Introducer, Catheter Cardiovascular Class 2 870.1340 2024-03-07
QBI Acute Coronary Syndrome Event Detector Unknown Class 3 N/A 2019-01-10

Official Correspondent

Mohit Malkani

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OSCOR 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
K190960 Boston Scientific Neuromodulation Nalu Lead Blank (50cm) 2019-07-11
K150517 Stimwave Technologies Incorporated Freedom Spinal Cord Stimulator System 2015-06-05
K945103 Medtronic Vascular TEMP AND PERMANENT NEURO LEADS (VARIOUS MODELS) 1995-01-11
K101883 St Jude Medical 6F ENGAGE/ENGAGE TR INTRODUCER 2010-09-07
K034025 Nmt Medical, Inc. NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC 2004-03-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0022-2018 St. Jude Medical, Inc. 3
Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667
Z-0024-2018 St. Jude Medical, Inc. 3
Proclaim DRG Implantable Pulse Generator Model 3664
Z-0025-2013 Advanced Neuromodulation Systems Inc. 3
The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectronic circuitry to generate constant current electrical stimulation. Stimulation programs can be delivered as either single stimulation or MultiStim programs depending on patients need. Product Usage: Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain.
Z-0458-2026 Abbott Medical 3
Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400
Z-2358-2024 Abbott Medical 3
Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1035166. Last updated year: 2026. Please use registration number 1035166 when referencing this establishment in official correspondence.
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