COAXIAL DILATOR SET— 510(k) K974640
Substantially EquivalentBoston Scientific Corp
FDA 510(k) clearance K974640 for COAXIAL DILATOR SET, Substantially Equivalent on 1998-03-13. Applicant: Boston Scientific Corp. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corp
- Product code
- Code DRE
- Device class
- Class 2
- Regulation
- 21 CFR 870.1310
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Natick,, MA, US
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Adverse events under product code DRE
product code DRE- Death
- 100
- Injury
- 832
- Malfunction
- 597
- Other
- 3
- Total
- 1,532
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.