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FDA 510(k)

PowerWire Radiofrequency Guidewire Kit

K-Number: K232562 · 2024-02-28

ApplicantBaylis Medical Technologies, Inc.
Decision Date2024-02-28
Product CodePDU
Advisory CommitteeCV
DecisionUnknown

Device Summary

PowerWire Radiofrequency Guidewire Kit is a medical device manufactured by Baylis Medical Technologies, Inc.. It received FDA 510(k) clearance on 2024-02-28 under approval number K232562. 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 Radiofrequency Guidewire Kit?

PowerWire Radiofrequency Guidewire Kit is a medical device that received FDA 510(k) clearance on 2024-02-28. It is manufactured by Baylis Medical Technologies, Inc.. The 510(k) number is K232562.

When was PowerWire Radiofrequency Guidewire Kit approved by the FDA?

PowerWire Radiofrequency Guidewire Kit received FDA 510(k) clearance on 2024-02-28, under approval number K232562.

What company makes PowerWire Radiofrequency Guidewire Kit?

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

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

The FDA product code for PowerWire 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) K250275PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch K251158PowerWire® 14 Radiofrequency Guidewire Kit 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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