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510(k) Data Aggregation
(269 days)
The Amplatzer™ Guidewire is intended to facilitate the introduction and exchange of a delivery system or catheter within the vasculature and chambers of the heart.
The Amplatzer™ Guidewire is 0.035-inch in diameter and made of a stainless steel core and a full length stainless steel spring coil coated with low-friction polytetrafluoroethylene (PTFE). The stainless steel core extends to the distal tip of the guidewire for one model (9-GW-001). Two models (9-GW-002 and 9-GW-003) have a stainless steel core that does not extend to the distal end of the wire. These models have an additional ribbon wire that runs parallel to the stainless steel core and extends to the distal end of the guidewire. The stainless steel core for all three models is tapered at the distal end of the guidewire to provide a smooth transition to the distal floppy segment.
The guidewires are available in two working lengths, 260 cm (9-GW-001 and 9‑GW‑002) and 300 cm (9-GW-003). The distal tip of the guidewire is available in two designs: a Modified J-Tip (9-GW-001) and a J-Tip (9-GW-002 and 9-GW-003). The J-straightener can be used to straighten the distal tip for all models. Model 9-GW-003 can also be manually straightened. The guidewire is sterile and for single use only.
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