Prelude SNAP Splittable Hydrophilic Sheath Introducer— 510(k) K152381
Substantially EquivalentMerit Medical Systems, Inc.
FDA 510(k) clearance K152381 for Prelude SNAP Splittable Hydrophilic Sheath Introducer, Substantially Equivalent on 2015-10-30. Applicant: Merit Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Merit Medical Systems, 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
- Malvern, PA, US
Recent devices under product code DYB
view allMore clearances from Merit Medical Systems, 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 K152381
K-number listed on FDA's recall record- Z-2575-2024 — Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Prelude SNAP-H (Introducer Catheter kit), REF: PLSH-1006/A PLSH-1007/A PLSH-1008/A PLSH-1009.5/A PLSH-2506/A PLSH-2507/A For the introduction of various types of pacing leads and catheters to the heart and coronary venous system.
- Z-0688-2018 — PreludeSNAP Splittable Hydrophilic and non-Hydrophilic Sheath Introducers, Catalog Numbers - PLS-1007, PLS-1008, PLS-1009, PLS-1009.5, PLS-1010, PLS-1010.5, PLS-1011, PLS-2506, PLS-2507, PLS-2508, PLS-2509, PLS-2510, PLS-2510.5, PLSH-1006, PLSH-1009, PLSX-1006, PLSX-1007, PLSX-1009, PLSX-1009.5
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152381.
Data sourced from openFDA. This site is unofficial and independent of the FDA.