Boss Crossing Support Catheter— 510(k) K220632
Substantially EquivalentMarvao Medical Devices, Ltd.
FDA 510(k) clearance K220632 for Boss Crossing Support Catheter, Substantially Equivalent on 2022-06-02. Applicant: Marvao Medical Devices, Ltd.. Device class: 2.
Clearance details
- Applicant
- Marvao Medical Devices, Ltd.
- 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
- Galway, IE
Recent devices under product code DQY
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- K143567 — NexSite HD Hemodialysis Split Tip Catheter for long term use (24cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (28cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (32cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (36cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (40cm), NexSite HD Hemodialysis Split Tip Catheter for long term use (55cm)
- K140492 — NEXSITE HD (55CM), HEMODIALYSIS CATHETER FOR LONG TERM USE
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.