FDA.reportPublic FDA data

510(k) K150882

Device
Edwards Suture Fastening System
Applicant
EDWARDS LIFESCIENCES, LLC.
510(k) number
K150882
Product code
HCF  
Decision
Substantially Equivalent (SESE)
Decision date
2015-06-16
Date received
2015-04-02
Regulation
878.4800
Classification name
Instrument, Ligature Passing And Knot Tying
Medical specialty
General & Plastic Surgery
Review panel
General & Plastic Surgery
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
NINA BROOKE
Address
One Edwards Way Irvine CA US 92614 92614

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HCF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K931379MICROVASIVE INSURG LAPTIE SUTURE LIGATORBoston Scientific Corp1993-07-13
K851452VALTRAC PURSESTING DEVICEDavis & Geck, Inc.1985-06-12
K841617STROVER HOOKPlastafil, Inc.1984-08-27
K790577HEMORRHOIDAL LIGATORJ. Sklar Mfg. Co., Inc.1979-04-23

Legacy Summary#

summary

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