Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004785273

FEI Number

3004785273

Entity Name

OSCOR CARIBE LLC

City/State/Country

SANTO DOMINGO Distrito Nacional, DO

Establishment Address

ZONA FRANCA LAS AMERICAS, NAVE A1-2, SANTO DOMINGO Distrito Nacional --, DO

Establishment Type(s)

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

Owner / Operator

OSCOR CARIBE LLC (Owner Number: 9068575)

Owner / Operator Contact Address

ZONA FRANCA LAS AMERICAS, NAVE A1-2, SANTO DOMINGO, DO-01 11606, DO

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Destino Twist, Steerable Guiding Catheter BIS/BLV, BLV/BIS Adelante Destino Steerable Guiding Sheath Breezeway II Adelante Sigma, Adelante Sigma AT Adelante Targa INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD TME MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS) iLINK TME BIS Series Adelante Breezeway Delivery Sheath Adelante Breezeway Delivery Sheath Adelante-S, Adelante-S Lite, Adelante-S2, Adelante-S RS, Adelante SII, SafeSheath II Adelante-S Series Introducer, Adelante Magnum Adelante Destino

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2014-06-06
DTD	Pacemaker Lead Adaptor	Cardiovascular	Class 2	870.3620	2008-03-07
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-03-29
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2021-10-29
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2012-12-04
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2022-05-27
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2008-03-07
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2022-05-27
DTD	Pacemaker Lead Adaptor	Cardiovascular	Class 2	870.3620	2008-03-07
LDF	Electrode, Pacemaker, Temporary	Cardiovascular	Class 2	870.3680	2008-11-17
DTD	Pacemaker Lead Adaptor	Cardiovascular	Class 2	870.3620	2008-03-10
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2013-03-29
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2010-12-31
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2012-09-20
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2014-08-07
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2012-09-20

Official Correspondent

Diogenes (DJ) Reyes

US Agent Details

Mohit Malkani Business: Oscor Inc. Email: mohit.malkani@integer.net Phone: (727) 9372511

Related Public Records

Same Entity

OSCOR CARIBE LLC

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
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
K122854	Arrow International (Subsidiary of Teleflex Inc.)	ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER	2013-01-04
K233691	Acutus Medical, Inc.	FlexCath Cross Transseptal Solution	2023-12-17
K915078	North American Instrument Corp.	MORSE HEMOSTATIC CATHETER INTRODUCER SET	1992-06-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Z-0002-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024	ARROW INTERNATIONAL Inc.	2	Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0009-2023	B Braun Medical Inc	2	Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004785273. Last updated year: 2026. Please use registration number 3004785273 when referencing this establishment in official correspondence.