ANGIOJET SOLENT OMNI THROMBECTOMY SET— 510(k) K111182
Substantially EquivalentMedrad, Inc.
FDA 510(k) clearance K111182 for ANGIOJET SOLENT OMNI THROMBECTOMY SET, Substantially Equivalent on 2011-05-24. Applicant: Medrad, Inc.. Device class: 2.
Clearance details
- Applicant
- Medrad, Inc.
- Product code
- Code QEZ
- Device class
- Class 2
- Regulation
- 21 CFR 870.5150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Minneapolis, MN, US
Recent devices under product code QEZ
view allMore clearances from Medrad, Inc.
view all- K133023 — JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6
- K130381 — ANGIOJET ULTRA POWER PULSE KIT
- K130637 — JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM
- K122916 — JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM
- K113363 — ANGIOJET SOLENT DISTA THROMBECTOMY SET
Adverse events under product code QEZ
product code QEZ- Death
- 24
- Total
- 24
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 K111182
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 K111182.
Data sourced from openFDA. This site is unofficial and independent of the FDA.