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FDA 510(k)

RVT CTO DEVICE

K-Number: K101599 · 2011-01-18

ApplicantRevascular Therapeutics, Inc.
Decision Date2011-01-18
Product CodePDU
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RVT CTO DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Revascular Therapeutics, Inc.. It received FDA 510(k) clearance on 2011-01-18 under 510(k) number K101599. 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 RVT CTO DEVICE?

RVT CTO DEVICE is a medical device that received FDA 510(k) clearance on 2011-01-18. The listed applicant is Revascular Therapeutics, Inc.. The 510(k) number is K101599.

When did RVT CTO DEVICE receive FDA 510(k) clearance?

RVT CTO DEVICE received FDA 510(k) clearance on 2011-01-18, under 510(k) number K101599.

Who is the listed applicant for RVT CTO DEVICE?

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

What is the FDA product code for RVT CTO DEVICE?

The FDA product code for RVT CTO DEVICE 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

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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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