Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter— 510(k) K160941
Substantially EquivalentBrosmed Medical Co., Ltd.
FDA 510(k) clearance K160941 for Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter, Substantially Equivalent on 2016-12-13. Applicant: Brosmed Medical Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Brosmed Medical Co., Ltd.
- Product code
- Code LIT
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dongguan, CN
Recent devices under product code LIT
view allMore clearances from Brosmed Medical Co., Ltd.
view allAdverse events under product code LIT
product code LIT- Death
- 27
- Injury
- 1,256
- Malfunction
- 12,127
- Total
- 13,410
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K160941
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160941.
Data sourced from openFDA. This site is unofficial and independent of the FDA.