Micro Catheter— 510(k) K243534
Substantially EquivalentSuzhou Zenith Vascular SciTech Limited
FDA 510(k) clearance K243534 for Micro Catheter, Substantially Equivalent on 2025-07-30. Applicant: Suzhou Zenith Vascular SciTech Limited. Device class: 2.
Clearance details
- Applicant
- Suzhou Zenith Vascular SciTech Limited
- Product code
- Code KRA
- Device class
- Class 2
- Regulation
- 21 CFR 870.1210
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suzhou, CN
Recent devices under product code KRA
view all- K254051 — Extroducer Infusion Catheter System
- K261610 — Verge Microcatheter
- K260771 — TruSelect 2.6 Microcatheter
- K250794 — InVera Infusion Device
- K231821 — XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)
More clearances from Suzhou Zenith Vascular SciTech Limited
view allAdverse events under product code KRA
product code KRA- Death
- 234
- Injury
- 1,029
- Malfunction
- 3,012
- Other
- 2
- Total
- 4,277
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.