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Single Pass Tunneling Guidewire - Large
ARKIS BIOSCIENCES INC. · Model 41.157.103 · UDI-DI 00866614000122
GYK
Prescription
10
510(k) clearances
15
Adverse events
1
Recalls
21
Facilities
Description
The Single Pass Tunneling Guidewire kit is designed to facilitate the subcutaneous passage of shunt tubing from a frontal scalp incision, or an incision on the neck, to an incision site on the torso when implanting a ventricular shunting system in patients greater than five (5) years old with a normal skull and normal skin.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-12-22 | Integra LifeSciences Corp. | Peritoneal Introducer Sheaths were incorrectly labeled as 61 cm instead of 46 cm. |
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