LLD EZ— 510(k) K142116
Substantially EquivalentSpectranetics, Inc.
FDA 510(k) clearance K142116 for LLD EZ, Substantially Equivalent on 2014-08-12. Applicant: Spectranetics, Inc.. Device class: 2.
Clearance details
- Applicant
- Spectranetics, Inc.
- Product code
- Code DRB
- Device class
- Class 2
- Regulation
- 21 CFR 870.1380
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Colorado Springs, CO, US
Recent devices under product code DRB
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Adverse events under product code DRB
product code DRB- Death
- 36
- Injury
- 562
- Total
- 598
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.