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

Name: FDA 510(k) clearance K971395
Creator: U.S. Food and Drug Administration
Published: 1997-07-14

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. Device class: 2.

Clearance details

Applicant: Target Therapeutics
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 1997-04-15
Decision date: 1997-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Freemont, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DQX

view all

K261281 — CROSSLEAD Standard 035 and CROSSLEAD Stiff 0352026-09-03
K253667 — Accoat Guide Wire2026-07-14
K261640 — Merit MAK Nitinol/Gold-Tungsten Guide Wire2026-07-13
K254137 — InQwire Amplatz Guide Wire2026-05-22
K260544 — FMD Peripheral Guide Wire F-14 Flex 6 +4 more2026-03-20

More clearances from Target Therapeutics

view all

K964488 — DETACHABLE SILICONE BALLOON (DSB)1998-04-21
K965071 — DETACHABLE SLICONE BALLOON (DSB)1998-04-21
K964210 — RETRIEVER II1997-10-31
K965189 — SPINNAKER1997-03-24
K964112 — BERENSTEIN COIL1997-02-26

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.