Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1220905

FEI Number

1220905

Entity Name

PRIMROSE MEDICAL, INC.

City/State/Country

East Walpole, MA, US

Establishment Address

286 Union Street, East Walpole, MA 02032, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PRIMROSE MEDICAL INC. (Owner Number: 1220905)

Owner / Operator Contact Address

286 Union Street, --, East Walpole, MA 02032, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K873493

PMA Number

N/A

All Registered Proprietary Names

Iv Cath

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2019-04-02
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2015-09-11
LJT	Port & Catheter, Implanted, Subcutaneous, Intravascular	General Hospital	Class 2	880.5965	2015-09-11
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2015-09-11
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2019-04-02

Official Correspondent

FLETCHER LONGLEY

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PRIMROSE MEDICAL 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
K943349	Quinton, Inc.	MAHURKAR DUAL LUMEN CATHETER	1995-03-22
K912158	Medical Device Inspection Co., Inc.	CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY	1991-10-23
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K912423	Med Institute, Inc.	VITAL-PORT M.R.I. VASCULAR ACCESS SYSTEM 7012,7112	1991-07-30
K961652	Arrow Intl., Inc.	LOW PROFILE PLASTIC PORT DETACHED CATHETER SYSTEM CATALOG #1017	1996-07-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0025-2024	Becton Dickinson Infusion Therapy Systems Inc.	2	REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1220905. Last updated year: 2026. Please use registration number 1220905 when referencing this establishment in official correspondence.