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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 the device name listed in this FDA 510(k) record. The listed applicant is Northeast Scientific, Inc.. It received FDA 510(k) clearance on 2022-07-01 under 510(k) 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. The listed applicant is Northeast Scientific, Inc.. The 510(k) number is K220171.

When did NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter?

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

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.

Related Clinical Trials

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.

NCT07743528A Prospective, Multicenter, Two-cohorts, Single Arm Study Evaluating Safety, Effectiveness and Performance of Angimis Atherectomy System for the Treatment of Non-crossable and/or Non-dilatablE Lesions in CorONary Arteries Disease (NEON Study).NOT_YET_RECRUITING

Other records listing Northeast Scientific, Inc. as applicant

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.

K250592NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)K223026NES Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterK200195NES Reprocessed Visions PV .014P RX Digital IVUS Catheter

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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