HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED— 510(k) K913312

Substantially Equivalent

Target Therapeutics

FDA 510(k) clearance K913312 for HELIX SHAPED COILS WITH DACRON FIBERS, MODIFIED, Substantially Equivalent on 1991-11-08. Applicant: Target Therapeutics.

Clearance details

Applicant: Target Therapeutics
Product code: Code HCG
Advisory panel: Neurology
Date received: 1991-07-25
Decision date: 1991-11-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

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Adverse events under product code HCG

product code HCG

Death: 50
Injury: 801
Malfunction: 5,625
Total: 6,476

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.