Submission Details
| 510(k) Number | K212215 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 15, 2021 |
| Decision Date | July 19, 2022 |
| Days to Decision | 369 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Tiche PTA Balloon Dilatation Catheter
Jul 2022
Decision
369d
Days
Class 2
Risk
About This 510(k) Submission
K212215 is an FDA 510(k) clearance for the Tiche PTA Balloon Dilatation Catheter, a Catheter, Angioplasty, Peripheral, Transluminal (Class II — Special Controls, product code LIT), submitted by Brosmed Medical Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on July 19, 2022, 369 days after receiving the submission on July 15, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.
Device Classification
| Product Code | LIT — Catheter, Angioplasty, Peripheral, Transluminal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
Manufacturer
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