MAMBA and MAMBA Flex Microcatheters— 510(k) K190401
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K190401 for MAMBA and MAMBA Flex Microcatheters, Substantially Equivalent on 2019-03-15. Applicant: Boston Scientific Corporation. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code DQY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Maple Grove, MN, US
Recent devices under product code DQY
view allMore clearances from Boston Scientific Corporation
view allAdverse events under product code DQY
product code DQY- Death
- 464
- Injury
- 4,489
- Malfunction
- 13,721
- Other
- 2
- Total
- 18,676
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 K190401
K-number listed on FDA's recall record- Z-1429-2021 — MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.
- Z-1430-2021 — MAMBA Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to the carton.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K190401.
Data sourced from openFDA. This site is unofficial and independent of the FDA.