FDA 510(k) Premarket Notification K151126: Foresight Intracardiac Echocardiography (ICE) System

Submission Details & Decision

Normalized public record details for 510(k) notification K151126.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K151126

Applicant / Sponsor

Colibri Technologies, Inc.

Device Name

Foresight Intracardiac Echocardiography (ICE) System

Product Code

DQO

Decision Date

2015-12-18

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Cardiovascular (CV)

Clearance Type

Traditional

Third Party Flag

Date Received

2015-04-28

Related Establishments / Registrations

Boston Scientific Corporation Registration: 1000121056 View Registration
AngioDynamics, Inc. Registration: 1000523114 View Registration
Cordis US Corp. Registration: 1016427 View Registration
C.R. BARD, INC. Registration: 1018233 View Registration
Sterigenics U.S., LLC Registration: 1018470 View Registration
OSCOR INC. Registration: 1035166 View Registration
DEROYAL INDUSTRIES, INC. Registration: 1043214 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1047843 View Registration
STERILIZATION SERVICES OF GEORGIA, INC. Registration: 1048735 View Registration
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STERILIZATION SERVICES OF VIRGINIA Registration: 1123137 View Registration
MEDTRONIC VASCULAR Registration: 1220452 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1220477 View Registration
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NUMED, INC. Registration: 1318694 View Registration
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Sterigenics U.S., LLC Registration: 1319639 View Registration
MEDLINE INDUSTRIES, LP - Northfield Registration: 1417592 View Registration
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MEDLINE INDUSTRIES, LP - SPT Registration: 1423395 View Registration
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BIOMERICS FMI Registration: 1646831 View Registration
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Sterigenics U.S., LLC Registration: 1721676 View Registration
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Terumo BCT STERILIZATION SERVICES, Inc. Registration: 1724474 View Registration
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ABBOTT VASCULAR Registration: 2024168 View Registration
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B. BRAUN MEDICAL INC. Registration: 2521402 View Registration
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PARALLEL DESIGN SAS Registration: 3003594449 View Registration
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Sterigenics US LLC Registration: 3004111573 View Registration
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TRI-STATE DE MEXICO, S. DE R.L. DE C.V. Registration: 3004519921 View Registration
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