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510(k) K011349

Device
INTERCOSTAL LOCKABLE-DIRECTABLE PORT
Applicant
MEDCANICA, INC.
510(k) number
K011349
Product code
DRC  
Decision
Substantially Equivalent (SESE)
Decision date
2001-10-05
Date received
2001-05-02
Regulation
870.1390
Classification name
Trocar
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CHRISTIAN L MAZZOLA
Address
19526 E. Lake Dr. Miami FL US 33015 33015

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DRC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K240246Accusafe Transseptal Guidewire (GTR31180, GTR31230)Synaptic Medical Corporation2024-07-26
K241042SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198)Pressure Products Medical Device Manufacturing, LLC2024-05-17
K221707SafeSept® Transseptal Guidewire (SS-140)Pressure Products Medical Device Manufacturing, LLC2022-09-14
K212625PathBuilder Transseptal NeedleShanghai Microport EP Medtech Co., Ltd.2022-03-23
K210328SafeSept Blunt NeedlePressure Products Medical Device Manufacturing, LLC2021-03-05
K172950TSN Transseptal NeedlePressure Products Medical Device Manufacturing, LLC2018-02-21
K172934Needle Free Transseptal CannulaPressure Products Medical Device Manufacturing, LLC2018-02-16
K172893SafeSept Needle Free Transseptal GuidewirePressure Products Medical Device Manufacturing, LLC2017-12-21
K170671SafeSept Transseptal GuidewirePressure Products Medical Device Manufacturing, LLC2017-10-20
K132943INTRACARDIC CATHETER INTRODUCER KIT AND TRANSSEPTAL NEEDLESynaptic Medical Limited2014-08-29
K130843SAFESEPT NEEDLE FREE TRANSSEPTAL TROCAR GUIDEWIREOscor, Inc.2014-01-08
K122587BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208St Jude Medical2013-02-07
K122832MOBICATH TRANSSEPTAL NEEDLEGreat Batch Medical2012-12-19
K111644MOBICATH TRANSSEPTAL NEEDLEGreat Batch Medical2011-10-03
K081986SAFESEPT TRANSSEPTAL TROCAR GUIDEWIREOscor, Inc.2008-11-14

Legacy Summary#

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FDA Review#

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