SPECTRANETICS VISISHEATH DILATOR SHEATH— 510(k) K092378

Substantially Equivalent

Spectranetics Corp.

FDA 510(k) clearance K092378 for SPECTRANETICS VISISHEATH DILATOR SHEATH, Substantially Equivalent on 2009-11-02. Applicant: Spectranetics Corp..

Clearance details

Applicant: Spectranetics Corp.
Product code: Code DRE
Advisory panel: Cardiovascular
Date received: 2009-08-05
Decision date: 2009-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Colorado Springs, CO, 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, 2020-01-01 through 2026-04-23. 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.