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Subcutaneous Guidewire - Large

ARKIS BIOSCIENCES INC. · Model 41.240.503 · UDI-DI 10866614000198

GYKMDMHAO Prescription
10
510(k) clearances
15
Adverse events
1
Recalls
21
Facilities

Description

The Subcutaneous Guidewire is designed to facilitate the subcutaneous passage of tubing, suture, ribbons, and/or bands between two skin incisions. It is also designed to facilitate the subcutaneous passage of shunt tubing when implanting a ventricular or lumbar cerebrospinal fluid (CSF) shunting system or externalized CSF drain.

Recalls

DateFirmReason
2010-12-22Integra LifeSciences Corp.Peritoneal Introducer Sheaths were incorrectly labeled as 61 cm instead of 46 cm.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.