510(k) K230884 ยท DQK Computer, Diagnostic, Programmable
AVVIGO'+ Multi-Modality Guidance System
| Applicant | Boston Scientific Corporation, Maple Grove MN, US |
| Decision | Substantially Equivalent, Sep 26, 2023 |
| Received | Mar 30, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230884
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2024 | Boston Scientific Corporation Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTEGRATED KIT; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intr Open, Classified |
DQK | None listed |
| Oct 16, 2024 | Boston Scientific Corporation Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or Open, Classified |
DQK | None listed |
| Oct 16, 2024 | Boston Scientific Corporation Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM - ZERO COST US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or in Open, Classified |
DQK | None listed |
| Oct 16, 2024 | Boston Scientific Corporation Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM EU + ROW; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracar Open, Classified |
DQK | None listed |
| Oct 16, 2024 | Boston Scientific Corporation Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardia Open, Classified |
DQK | None listed |
| Oct 16, 2024 | Boston Scientific Corporation Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac a Open, Classified |
DQK | None listed |
| Oct 16, 2024 | Boston Scientific Corporation Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST EU + RO; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/ Open, Classified |
DQK | None listed |
| Oct 16, 2024 | Boston Scientific Corporation Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or Open, Classified |
DQK | None listed |
| Oct 16, 2024 | Boston Scientific Corporation Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or in Open, Classified |
DQK | None listed |
| Oct 16, 2024 | Boston Scientific Corporation Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EU + ROW; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracar Open, Classified |
DQK | None listed |
| Oct 16, 2024 | Boston Scientific Corporation Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - ZERO COST US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/ Open, Classified |
DQK | None listed |
| Oct 16, 2024 | Boston Scientific Corporation Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL EU + ROW; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or int Open, Classified |
DQK | None listed |
| Oct 16, 2024 | Boston Scientific Corporation Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracard Open, Classified |
DQK | None listed |
| Oct 16, 2024 | Boston Scientific Corporation Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardia Open, Classified |
DQK | None listed |
| Oct 16, 2024 | Boston Scientific Corporation Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac a Open, Classified |
DQK | None listed |
| Oct 16, 2024 | Boston Scientific Corporation Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + INT Z UPGRADE JP; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/o Open, Classified |
DQK | None listed |
| Oct 16, 2024 | Boston Scientific Corporation Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + MOB Z UPGRADE JP; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/o Open, Classified |
DQK | None listed |
| Oct 16, 2024 | Boston Scientific Corporation Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or Open, Classified |
DQK | None listed |
| Oct 16, 2024 | Boston Scientific Corporation Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or in Open, Classified |
DQK | None listed |
| Oct 16, 2024 | Boston Scientific Corporation Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE EU ROW; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/o Open, Classified |
DQK | None listed |
| Oct 16, 2024 | Boston Scientific Corporation Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or Open, Classified |
DQK | None listed |
| Oct 16, 2024 | Boston Scientific Corporation Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or in Open, Classified |
DQK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.