INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED)— 510(k) K980578

Substantially Equivalent

Innerdyne, Inc.

FDA 510(k) clearance K980578 for INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED), Substantially Equivalent on 1998-09-11. Applicant: Innerdyne, Inc..

Clearance details

Applicant: Innerdyne, Inc.
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 1998-02-17
Decision date: 1998-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

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Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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.