CONCENTRIC BALLOON GUIDE CATHETER— 510(k) K112404
Substantially EquivalentConcentric Medical, Inc.
FDA 510(k) clearance K112404 for CONCENTRIC BALLOON GUIDE CATHETER, Substantially Equivalent on 2012-03-15. Applicant: Concentric Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Concentric Medical, Inc.
- Product code
- Code DQY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mountain View, CA, US
Recent devices under product code DQY
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 DQY
product code DQY- Death
- 464
- Injury
- 4,489
- Malfunction
- 13,721
- Other
- 2
- Total
- 18,676
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 K112404
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 K112404.
Data sourced from openFDA. This site is unofficial and independent of the FDA.