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FDA 510(k)

NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter

K-Number: K220171 · 2022-07-01

ApplicantNortheast Scientific, Inc.
Decision Date2022-07-01
Product CodeQTF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter is a medical device manufactured by Northeast Scientific, Inc.. It received FDA 510(k) clearance on 2022-07-01 under approval number K220171. The device is classified under product code QTF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter?

NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter is a medical device that received FDA 510(k) clearance on 2022-07-01. It is manufactured by Northeast Scientific, Inc.. The 510(k) number is K220171.

When was NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter approved by the FDA?

NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter received FDA 510(k) clearance on 2022-07-01, under approval number K220171.

What company makes NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter?

NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter is manufactured by Northeast Scientific, Inc..

What is the FDA product code for NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter?

The FDA product code for NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter is QTF.

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Other Devices by Northeast Scientific, Inc.

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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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