FDA.reportPublic FDA data

510(k) K951448

Device
GLOBAL MEDICAL PRODUCTS POTTS COURNAND, SELDINGER STYLE NEEDLE, SINGLE, WINGED SINGLE WALL INTRODUCER NEEDLE
Applicant
GLOBAL MEDICAL PRODUCTS, LTD.
510(k) number
K951448
Product code
DRC  
Decision
Substantially Equivalent (SESE)
Decision date
1996-03-27
Date received
1995-03-29
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

Applicant Contact#

Contact
PETER CLARK
Address
Omar Hodge Bldg. Wickhams Cay 1, P.O. Box 362 Road Town, Tortola VG

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases