USCI GRUNTZIG DILACA CORNARY BALLOON DILATATION CA
FDA premarket approval P790017/S001 · decided 1981-02-17
Approval details
- PMA number
- P790017
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Trade name
- USCI GRUNTZIG DILACA CORNARY BALLOON DILATATION CA
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Medtronic, Ireland
- Date received
- 1980-12-22
- Decision date
- 1981-02-17
- Days to decision
- 57 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
| Record | Firm | Date |
|---|---|---|
| Euphora Rapid Exchange (RX) Balloon Dilatation Catheter (K261759) | Medtronic Ireland | 2026-07-27 |
| Sprinter Legend Rapid Exchange Balloon Dilatation Catheter (K251970) | Medtronic, Ireland | 2026-01-17 |
| Telescope Guide Extension Catheter (K252390) | Medtronic, Ireland | 2025-10-29 |
| Liberant Thrombectomy System (K250787) | Medtronic, Ireland | 2025-06-11 |
| ATTAIN COMMAND+SUREVALVE LEFT HEART DELIVERY SYSTEM ATTAIN COMMAND GUIDE CATHETERS FOR LEFT HEART DELIVERY,ATTAIN SELECT (K123153) | Medtronic, Ireland | 2013-04-09 |
| SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON (K103095) | Medtronic, Ireland | 2010-10-22 |
| ATTAIN 6227DEF DEFLECTABLE CATHETER DELIVERY SYSTEM (K061480) | Medtronic, Ireland | 2006-08-21 |
| ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM (K053431) | Medtronic, Ireland | 2006-03-16 |