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FDA 510(k)

PowerWire® 14 Radiofrequency Guidewire Kit

K-Number: K251158 · 2025-09-11

ApplicantBaylis Medical Technologies, Inc.
Decision Date2025-09-11
Product CodePDU
Advisory CommitteeCV
DecisionUnknown

Device Summary

PowerWire® 14 Radiofrequency Guidewire Kit is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Technologies, Inc.. It received FDA 510(k) clearance on 2025-09-11 under 510(k) number K251158. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the PowerWire® 14 Radiofrequency Guidewire Kit?

PowerWire® 14 Radiofrequency Guidewire Kit is a medical device that received FDA 510(k) clearance on 2025-09-11. The listed applicant is Baylis Medical Technologies, Inc.. The 510(k) number is K251158.

When did PowerWire® 14 Radiofrequency Guidewire Kit receive FDA 510(k) clearance?

PowerWire® 14 Radiofrequency Guidewire Kit received FDA 510(k) clearance on 2025-09-11, under 510(k) number K251158.

Who is the listed applicant for PowerWire® 14 Radiofrequency Guidewire Kit?

The FDA 510(k) record lists Baylis Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PowerWire® 14 Radiofrequency Guidewire Kit?

The FDA product code for PowerWire® 14 Radiofrequency Guidewire Kit is PDU.

Other records listing Baylis Medical Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254114Baylis Connector CableK250275PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ FootswitchK232562PowerWire Radiofrequency Guidewire KitK230571RFP-100A Connector Cable (Single Use)

Related Devices (Code: PDU)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252315Santreva™-ATK Endovascular Revasculariztion CatheterAngioSafe, Inc.K251376LimFlow ARCLimFlow, Inc.K232562PowerWire Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.K230159SoundBite® Crossing System XS PeripheralSoundbite Medical Solutions, Inc.K230594Tigereye ST CTO-Crossing CatheterAvinger, Inc.K221163Tunnel Crossing CatheterTractus Vascular, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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