Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005102565

FEI Number

3005102565

Entity Name

CARDIAC DIMENSIONS, INC.

City/State/Country

Kirkland, WA, US

Establishment Address

5540 LAKE WASHINGTON BLVD NE, Kirkland, WA 98033, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

Cardiac Dimensions Inc (Owner Number: 10050092)

Owner / Operator Contact Address

5540 Lake Washington Blvd. NE, Kirkland, WA 98033, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CARILLON® Mitral Contour System Implant/Handle CARILLON® Curved Delivery Catheter CARILLON® Sizing Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NKM	Mitral Valve Repair Devices	Unknown	Class 3	N/A	2015-10-12

Official Correspondent

Robert Calcote

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cardiac Dimensions Inc

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005102565. Last updated year: 2026. Please use registration number 3005102565 when referencing this establishment in official correspondence.