Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013634084

FEI Number

3013634084

Entity Name

SIS MEDICAL AG

City/State/Country

Frauenfeld Thurgau, CH

Establishment Address

Hungerbueelstr. 12A, Frauenfeld Thurgau 8500, CH

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SIS Medical AG (Owner Number: 10086262)

Owner / Operator Contact Address

Hungerbueelstr. 12A, Frauenfeld, CH-TG 8500, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212393

PMA Number

N/A

All Registered Proprietary Names

OPN NC PTCA Dilatation Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Cardiovascular	Class 2	870.5100	2022-10-26

Official Correspondent

Tanja Bleuler

US Agent Details

SEMIH OKTAY Business: CardioMed Device Consultants, LLC Email: soktay@cardiomedllc.com Phone: (410) 6742060

Related Public Records

Same Entity

SIS Medical AG

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011
Z-0031-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051
Z-0032-04	N/A	2	Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013634084. Last updated year: 2026. Please use registration number 3013634084 when referencing this establishment in official correspondence.