510(k) K970341

Device

MEDTRONIC PS MEDICAL RIVAS VASCULAR CATHETER REPAIR KIT

Applicant

MEDTRONIC PS MEDICAL

510(k) number

K970341

Product code

LIS

Decision

Substantially Equivalent (SESE)

Decision date

1997-04-23

Date received

1997-01-29

Regulation

510(k) Premarket Notification

Classification name

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products   510(k) Premarket Notification Var MP = { Version: '1.0.22', Domains: {'es':'esp.fda.gov'}, SrcLang: 'en', UrlLang: 'mp_js_current_la

Medical specialty

510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices

Review panel

General Hospital

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No