FDA.report

510(k) K972201

Device
PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENE
Applicant
SULZER CARBOMEDICS, INC.
510(k) number
K972201
Product code
DXZ  
Decision
Substantially Equivalent (SESE)
Decision date
1998-04-14
Date received
1997-06-11
Regulation
870.3470
Classification name
Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
EDWARD E NEWTON
Address
1300 E. Anderson Ln. Austin TX US 78752 78752

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

Primary DIBrandCompanyPublished
05037881010618Gelsoft™ Cardiovascular PatchVASCUTEK LTD2019-02-16
05037881010434Gelseal™ Cardiovascular PatchVASCUTEK LTD2019-02-16
05037881011103Flouropassiv™VASCUTEK LTD2015-10-22
05037881011097Flouropassiv™VASCUTEK LTD2015-10-22
05037881011080Flouropassiv™VASCUTEK LTD2015-10-22
05037881011073Flouropassiv™VASCUTEK LTD2015-10-22
05037881011066Flouropassiv™VASCUTEK LTD2015-10-22
05037881011059Flouropassiv™VASCUTEK LTD2015-10-22
05037881011042Flouropassiv™VASCUTEK LTD2015-10-22
05037881011035Flouropassiv™VASCUTEK LTD2015-10-22
05037881011028Flouropassiv™VASCUTEK LTD2015-10-22
05037881011011Flouropassiv™VASCUTEK LTD2015-10-22
05037881003238Flouropassiv™VASCUTEK LTD2015-10-22

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