15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set— 510(k) K191871
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K191871 for 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set, Substantially Equivalent on 2019-08-07. Applicant: Boston Scientific Corporation. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code DYB
- Device class
- Class 2
- Regulation
- 21 CFR 870.1340
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Maple Grove, MN, US
Recent devices under product code DYB
view allMore clearances from Boston Scientific Corporation
view allAdverse events under product code DYB
product code DYB- Death
- 808
- Injury
- 5,922
- Malfunction
- 16,516
- Other
- 5
- Total
- 23,251
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 K191871
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 K191871.
Data sourced from openFDA. This site is unofficial and independent of the FDA.