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USCI GRUNTZIG DILACA CATHETER

FDA premarket approval P790017/S007 · decided 1983-12-14

Approval details

PMA number
P790017
Supplement
S007
Trade name
USCI GRUNTZIG DILACA CATHETER
Generic name
Catheters, transluminal coronary angioplasty, percutaneous
Applicant
Medtronic, Ireland
Date received
1983-07-22
Decision date
1983-12-14
Days to decision
145 days
Decision code
APPR
Product code
LOX
Advisory committee
Cardiovascular
Expedited review
No
Location
Galway

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510(k) clearances by this applicant

RecordFirmDate
Euphora Rapid Exchange (RX) Balloon Dilatation Catheter (K261759)Medtronic Ireland2026-07-27
Sprinter Legend Rapid Exchange Balloon Dilatation Catheter (K251970)Medtronic, Ireland2026-01-17
Telescope Guide Extension Catheter (K252390)Medtronic, Ireland2025-10-29
Liberant Thrombectomy System (K250787)Medtronic, Ireland2025-06-11
ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT (K123153)Medtronic, Ireland2013-04-09
SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON (K103095)Medtronic, Ireland2010-10-22
ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM (K061480)Medtronic, Ireland2006-08-21
ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM (K053431)Medtronic, Ireland2006-03-16