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FDA 510(k)

POWERWIRE RADIOFREQUENCY GUIDEWIRE

K-Number: K101615 · 2010-07-28

ApplicantBaylis Medical Co., Inc.
Decision Date2010-07-28
Product CodePDU
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

POWERWIRE RADIOFREQUENCY GUIDEWIRE is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Co., Inc.. It received FDA 510(k) clearance on 2010-07-28 under 510(k) number K101615. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWERWIRE RADIOFREQUENCY GUIDEWIRE?

POWERWIRE RADIOFREQUENCY GUIDEWIRE is a medical device that received FDA 510(k) clearance on 2010-07-28. The listed applicant is Baylis Medical Co., Inc.. The 510(k) number is K101615.

When did POWERWIRE RADIOFREQUENCY GUIDEWIRE receive FDA 510(k) clearance?

POWERWIRE RADIOFREQUENCY GUIDEWIRE received FDA 510(k) clearance on 2010-07-28, under 510(k) number K101615.

Who is the listed applicant for POWERWIRE RADIOFREQUENCY GUIDEWIRE?

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

What is the FDA product code for POWERWIRE RADIOFREQUENCY GUIDEWIRE?

The FDA product code for POWERWIRE RADIOFREQUENCY GUIDEWIRE is PDU.

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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.

K262013Kiba CTO Crossing CatheterReflow Medical, Inc.K252315Santreva™-ATK Endovascular Revasculariztion CatheterAngioSafe, Inc.K251158PowerWire® 14 Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.K251376LimFlow ARCLimFlow, Inc.K232562PowerWire Radiofrequency Guidewire KitBaylis Medical Technologies, Inc.K230159SoundBite® Crossing System XS PeripheralSoundbite Medical Solutions, Inc.

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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