Submission Details
| 510(k) Number | K203390 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 18, 2020 |
| Decision Date | April 14, 2021 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Artimes pro Balloon Dilatation Catheter
Apr 2021
Decision
147d
Days
Class 2
Risk
About This 510(k) Submission
K203390 is an FDA 510(k) clearance for the Artimes pro 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 14, 2021, 147 days after receiving the submission on November 18, 2020. 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
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