Submission Details
| 510(k) Number | K242969 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 26, 2024 |
| Decision Date | October 25, 2024 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
Pantera Pro; Pantera LEO
Oct 2024
Decision
29d
Days
Class 2
Risk
About This 510(k) Submission
K242969 is an FDA 510(k) clearance for the Pantera Pro; Pantera LEO, a Catheters, Transluminal Coronary Angioplasty, Percutaneous (Class II — Special Controls, product code LOX), submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on October 25, 2024, 29 days after receiving the submission on September 26, 2024. 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. |
Manufacturer
Similar Devices — LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
All 82
K251970 · Medtronic, Ireland
· Jan 2026
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
More from Biotronik, Inc.
View all
K250706
· LIT · Apr 2025
K240787
· DQY · Sep 2024
K241711
· LIT · Jul 2024
K230375
· MXD · May 2023
K222065
· LIT · Feb 2023