Submission Details
| 510(k) Number | K160941 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 04, 2016 |
| Decision Date | December 13, 2016 |
| Days to Decision | 253 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter
Dec 2016
Decision
253d
Days
Class 2
Risk
About This 510(k) Submission
K160941 is an FDA 510(k) clearance for the Castor, Achilles and Hermes NC 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 December 13, 2016, 253 days after receiving the submission on April 4, 2016. 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
Similar Devices — LIT Catheter, Angioplasty, Peripheral, Transluminal
All 401
K252512 · Abbott Medical
· Feb 2026
K251915 · Natec Medical , Ltd.
· Dec 2025
K250706 · Biotronik, Inc.
· Apr 2025
K243704 · Brosmed Medical Co., Ltd.
· Feb 2025
K241040 · Natec Medical , Ltd.
· Dec 2024
K242419 · Creagh Medical Ltd. Dba Surmodics, Inc.
· Nov 2024
More from Brosmed Medical Co., Ltd.
View all
K243704
· LIT · Feb 2025
K241478
· PNO · Oct 2024
K230705
· LOX · Apr 2023
K212215
· LIT · Jul 2022
K203390
· LOX · Apr 2021