FDA.report

510(k) K940036

Device
ENDOSURG DISPOSABLE SECONDARY TROCAR
Applicant
ENDOSURG
510(k) number
K940036
Product code
DRC  
Decision
Substantially Equivalent (SESE)
Decision date
1994-05-12
Date received
1994-01-04
Regulation
870.1390
Classification name
Trocar
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
STEVE HOLLOWAY
Address
4227 Centergate San Antonio TX US 78217 78217

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Other 510(k) Records For Product Code DRC  

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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