FlexSeal Introducer Sheath with Hydrophilic Coating— 510(k) K190628
Substantially EquivalentFreudenberg Medical Mis, Inc.
FDA 510(k) clearance K190628 for FlexSeal Introducer Sheath with Hydrophilic Coating, Substantially Equivalent on 2019-05-30. Applicant: Freudenberg Medical Mis, Inc.. Device class: 2.
Clearance details
- Applicant
- Freudenberg Medical Mis, Inc.
- 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
- Traditional
- Location
- Jeffersonville, IN, US
Recent devices under product code DYB
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 K190628
K-number listed on FDA's recall record- Z-1016-2022 — Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-100 (US)
- Z-1017-2022 — Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model: 668782-200 (OUS)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K190628.
Data sourced from openFDA. This site is unofficial and independent of the FDA.