FDA.reportPublic FDA data

510(k) K992476

Device
PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS
Applicant
PILLING WECK SURGICAL
510(k) number
K992476
Product code
MWS  
Decision
Substantially Equivalent (SESE)
Decision date
2000-09-13
Date received
1999-07-26
Regulation
870.4500
Classification name
Stabilizer, Heart
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
RICHARD G JONES
Address
420 Delaware Dr. Fort Washington PA US 19034 19034

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code MWS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K041338MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIESMedtronic Vascular2004-07-19
K992833VACUUM ASSIST STABILIZERCardio Thoracic Systems1999-11-10
K982419HEART-LIFT BALLOON POSITIONERCardiothoracic Systems, Inc.1999-01-13

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