SoloPath Re-Collapsible Access System— 510(k) K152498
Substantially EquivalentOnset Medical Corporation
FDA 510(k) clearance K152498 for SoloPath Re-Collapsible Access System, Substantially Equivalent on 2016-01-05. Applicant: Onset Medical Corporation. Device class: 2.
Clearance details
- Applicant
- Onset Medical 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
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code DYB
view allMore clearances from Onset Medical 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 K152498
K-number listed on FDA's recall record- Z-1375-2019 — SOLOPATH Re-Collapsible Access System, Model Numbers SR-1925, SR-1935, SR-2025, SR-2035, SR-2225, SR-2235, SR-2425, SR-2435
- Z-1376-2019 — Portico Solo Re-Collapsible Access System , Model Numbers PRTSOLO-19, PRTSOLO-20
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152498.
Data sourced from openFDA. This site is unofficial and independent of the FDA.