MODIFICATION TO MERCI RETRIEVER— 510(k) K082034
Substantially EquivalentConcentric Medical, Inc.
FDA 510(k) clearance K082034 for MODIFICATION TO MERCI RETRIEVER, Substantially Equivalent on 2008-08-15. Applicant: Concentric Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Concentric Medical, Inc.
- Product code
- Code NRY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mountain View, CA, US
Recent devices under product code NRY
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 NRY
product code NRY- Death
- 411
- Injury
- 1,712
- Malfunction
- 1,855
- Total
- 3,978
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 K082034
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 K082034.
Data sourced from openFDA. This site is unofficial and independent of the FDA.