Submission Details
| 510(k) Number | K251970 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 26, 2025 |
| Decision Date | January 17, 2026 |
| Days to Decision | 205 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
K251970 - Sprinter Legend Rapid Exchange Balloon Dilatation Catheter
(FDA 510(k) Clearance)
Jan 2026
Decision
205d
Days
Class 2
Risk
K251970 is an FDA 510(k) clearance for the Sprinter Legend Rapid Exchange Balloon Dilatation Catheter, a Catheters, Transluminal Coronary Angioplasty, Percutaneous (Class II — Special Controls, product code LOX), submitted by Medtronic, Ireland (Galway, IE). The FDA issued a Cleared decision on January 17, 2026, 205 days after receiving the submission on June 26, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5100.
Device Classification
| Product Code | LOX — Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.5100 |
| Definition | A Ptca Catheter Is A Device That Operates On The Principle Of Hydraulic Pressurization Applied Through An Inflatable Balloon Attached To The Distal End. |
Similar Devices — LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
All 82
K242969 · Biotronik, Inc.
· Oct 2024
K233499 · OrbusNeich Medical (Shenzhen) Co., Ltd.
· Aug 2024
K233505 · OrbusNeich Medical (Shenzhen) Co., Ltd.
· Aug 2024
K233729 · Vascular Solutions, LLC
· May 2024
K223189 · Shanghai MicroPort Medical (Group) Co., Ltd.
· Jul 2023
K230374 · Dongguan TT Medical, Inc.
· Jun 2023