HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131— 510(k) K091703
Substantially EquivalentConcentric Medical, Inc.
FDA 510(k) clearance K091703 for HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131, Substantially Equivalent on 2009-10-14. Applicant: Concentric Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Concentric Medical, 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
- Traditional
- Location
- Mountain View, CA, US
Recent devices under product code QEZ
view allMore clearances from Concentric Medical, Inc.
view all- K173352 — Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)
- DEN150049 — Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm
- K150616 — Trevo XP ProVue Retriever (4x30mm)
- K143077 — Trevo XP ProVue Retriever (6X25mm)
- K133177 — MODIFIED HD GUIDE CATHETER
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.