INTRODUCER SET, MODEL ADELANTE-S SERIES— 510(k) K122084
Substantially EquivalentOscor, Inc.
FDA 510(k) clearance K122084 for INTRODUCER SET, MODEL ADELANTE-S SERIES, Substantially Equivalent on 2012-08-29. Applicant: Oscor, Inc.. Device class: 2.
Clearance details
- Applicant
- Oscor, 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
- Special
- Location
- Palm Harbor, FL, US
Recent devices under product code DYB
view allMore clearances from Oscor, Inc.
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 K122084
K-number listed on FDA's recall record- Z-2678-2026 — Abiomed REF: 0052-3025, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F 13cm and 25cm. heart pump and accessories.
- Z-2679-2026 — Abiomed REF: 0052-3021, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 14F, 23F. heart pump and accessories.
- Z-2680-2026 — Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.
- Z-1467-2021 — AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122084.
Data sourced from openFDA. This site is unofficial and independent of the FDA.