MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456— 510(k) K041727
Substantially EquivalentBoston Scientific Scimed, Inc.
FDA 510(k) clearance K041727 for MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456, Substantially Equivalent on 2004-07-23. Applicant: Boston Scientific Scimed, Inc.. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Scimed, Inc.
- Product code
- Code OBJ
- 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
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Adverse events under product code OBJ
product code OBJ- Death
- 38
- Injury
- 634
- Malfunction
- 3,453
- Total
- 4,125
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.