Submission Details
| 510(k) Number | K153742 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 28, 2015 |
| Decision Date | August 08, 2016 |
| Days to Decision | 224 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Apollo Balloon Dilatation Catheter
Aug 2016
Decision
224d
Days
Class 2
Risk
About This 510(k) Submission
K153742 is an FDA 510(k) clearance for the Apollo 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 August 8, 2016, 224 days after receiving the submission on December 28, 2015. 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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