ISIGHT IMAGING CATHETER, MODEL 38986— 510(k) K060175
Substantially EquivalentBoston Scientific Corp
FDA 510(k) clearance K060175 for ISIGHT IMAGING CATHETER, MODEL 38986, Substantially Equivalent on 2006-03-24. Applicant: Boston Scientific Corp. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corp
- Product code
- Code DQO
- Device class
- Class 2
- Regulation
- 21 CFR 870.1200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Fremont, CA, US
Recent devices under product code DQO
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- K254278 — Arterial Pressure Monitoring Set/Tray
- K250751 — DualView Catheter
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More clearances from Boston Scientific Corp
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- K150692 — AXIOS Stent with Electrocautery Enhanced Delivery System
- K150303 — XXL Vascular Balloon Dilatation Catheter
Adverse events under product code DQO
product code DQO- Death
- 35
- Injury
- 993
- Malfunction
- 1,772
- Other
- 5
- Total
- 2,805
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.