Submission Details
| 510(k) Number | K230705 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 14, 2023 |
| Decision Date | April 11, 2023 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
POT PTCA Balloon Dilatation Catheter
Apr 2023
Decision
28d
Days
Class 2
Risk
About This 510(k) Submission
K230705 is an FDA 510(k) clearance for the POT PTCA Balloon Dilatation Catheter, a Catheters, Transluminal Coronary Angioplasty, Percutaneous (Class II — Special Controls, product code LOX), submitted by Brosmed Medical Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on April 11, 2023, 28 days after receiving the submission on March 14, 2023. 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
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
More from Brosmed Medical Co., Ltd.
View all
K243704
· LIT · Feb 2025
K241478
· PNO · Oct 2024
K212215
· LIT · Jul 2022
K203390
· LOX · Apr 2021
K160941
· LIT · Dec 2016