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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 a medical device manufactured by Baylis Medical Technologies, Inc.. It received FDA 510(k) clearance on 2025-09-11 under approval 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. It is manufactured by Baylis Medical Technologies, Inc.. The 510(k) number is K251158.

When was PowerWire® 14 Radiofrequency Guidewire Kit approved by the FDA?

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

What company makes PowerWire® 14 Radiofrequency Guidewire Kit?

PowerWire® 14 Radiofrequency Guidewire Kit is manufactured by Baylis Medical Technologies, Inc..

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

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

Related Clinical Trials

NCT07515040 Comparative Study on the Safety and Efficacy of Using AccuSafe Transseptal Guidewire Versus Traditional Transseptal Needle for Transseptal Puncture in non-or Free- Guidance RECRUITING

Other Devices by Baylis Medical Technologies, Inc.

K230571RFP-100A Connector Cable (Single Use) K232562PowerWire Radiofrequency Guidewire Kit K250275PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch K254114Baylis Connector Cable

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Official Source

View on FDA Database →

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

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