URESIL DILATOR WITH RADIOPAQUE MARKER— 510(k) K980282

Substantially Equivalent

Uresil Corp.

FDA 510(k) clearance K980282 for URESIL DILATOR WITH RADIOPAQUE MARKER, Substantially Equivalent on 1998-04-24. Applicant: Uresil Corp..

Clearance details

Applicant: Uresil Corp.
Product code: Code DRE
Advisory panel: Cardiovascular
Date received: 1998-01-26
Decision date: 1998-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Skokie, IL, 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.