GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN LIQUID COIL, FIBERED PLATINUM COILS, ACCE— 510(k) K971395

Substantially Equivalent

Target Therapeutics

FDA 510(k) clearance K971395 for GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN LIQUID COIL, FIBERED PLATINUM COILS, ACCE, Substantially Equivalent on 1997-07-14. Applicant: Target Therapeutics.

Clearance details

Applicant: Target Therapeutics
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 1997-04-15
Decision date: 1997-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Freemont, CA, US

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Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

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.