RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL— 510(k) K961445

Name: FDA 510(k) clearance K961445
Creator: U.S. Food and Drug Administration
Published: 1996-07-09

Substantially Equivalent

Terumo Medical Corp.

FDA 510(k) clearance K961445 for RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL, Substantially Equivalent on 1996-07-09. Applicant: Terumo Medical Corp.. Device class: 2.

Clearance details

Applicant: Terumo Medical Corp.
Product code: Code DQX
Device class: Class 2
Regulation: 21 CFR 870.1330
Advisory panel: Cardiovascular
Date received: 1996-04-16
Decision date: 1996-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, US

Download summary PDF View on FDA.gov ↗

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More clearances from Terumo Medical Corp.

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K111606 — PINNACLE PRECISION ACCESS SYSTEM2011-10-03
K111556 — GLIDECROSS SUPPORT CATHETER2011-07-29
K110540 — TERUMO SUPPORT CATHETER2011-05-13
K102008 — GLIDESHEATH2010-07-21
K091329 — PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH2009-05-29

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.