Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007146453

FEI Number

3007146453

Entity Name

MERMAID MEDICAL A/S

City/State/Country

Stenloese Hovedstaden, DK

Establishment Address

Frydensbergvej 25, Stenloese Hovedstaden DK-3660, DK

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Mermaid Medical (Owner Number: 10045264)

Owner / Operator Contact Address

8033 Cooper Creek Blvd, Unit 106, University Park, FL 34201, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K935170

PMA Number

N/A

All Registered Proprietary Names

Angel® Catheter Accessory Kit Angel® Catheter M-Biopsy M-Drain Percutaneous Introducer System Angel® Catheter Accesory Kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PNS	Short-Term Intravascular Filter Catheter	Cardiovascular	Class 2	870.3375	2019-11-27
DWO	Needle, Biopsy, Cardiovascular	General, Plastic Surgery	Class 1	878.4800	2013-11-21
DRE	Dilator, Vessel, For Percutaneous Catheterization	Cardiovascular	Class 2	870.1310	2013-11-29
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2019-11-27

Official Correspondent

Matthew Genzman

US Agent Details

Matthew Genzman Business: Mermaid Medical Email: mge@mermaidmedical.com Phone: (941) 8672129

Related Public Records

Same Entity

Mermaid Medical

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3027260597	Mermaid Medical A/S (FL Site)	University Park, FL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150445	Asahi Intecc Co., Ltd.	ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)	2015-06-30
K082922	Lake Region Mfg., Inc.	FREEWAY AND RAILRUNNER GUIDEWIRES	2008-12-09
K890207	E-Z-Em, Inc.	INTERVENTIONAL PRODUCTS - GUIDE WIRES	1989-05-31
K992169	Advanced Cardiovascular Systems, Inc.	ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE	1999-10-28
K012534	Advanced Cardiovascular Systems, Inc.	HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING	2002-01-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Z-0031-2009	Boston Scientific Corporation	2	Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01760-1537, Made in USA: 8600 NW 41st Street, Miami, FL 33166-6202. The Platinum Plus" Guidewire facilitates placement of a catheter during diagnostic or interventional intravascular procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.

Similar Registrations

Registration Number	Establishment Name	Location
1721676	Sterigenics U.S., LLC	Salt Lake City, UT, US
3004857851	HISTO S.A.	VILLA RAFFO Buenos Aires, AR
3015225571	Merit Medical Asia Company Limited	Tsim Sha Tsui, HK
3014761220	WENZHOU AOCHANG MISAWA MEDICAL TECH. CO., LTD	Wenzhou Zhejiang, CN
3005273623	Heuer International (A division of GST Corporation Limited)	NOIDA Uttar Pradesh, IN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007146453. Last updated year: 2026. Please use registration number 3007146453 when referencing this establishment in official correspondence.