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FDA 510(k)

Trevo Trak 21 Microcatheter

K-Number: K192122 · 2019-11-22

ApplicantStryker
Decision Date2019-11-22
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Trevo Trak 21 Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Stryker. It received FDA 510(k) clearance on 2019-11-22 under 510(k) number K192122. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Trevo Trak 21 Microcatheter?

Trevo Trak 21 Microcatheter is a medical device that received FDA 510(k) clearance on 2019-11-22. The listed applicant is Stryker. The 510(k) number is K192122.

When did Trevo Trak 21 Microcatheter receive FDA 510(k) clearance?

Trevo Trak 21 Microcatheter received FDA 510(k) clearance on 2019-11-22, under 510(k) number K192122.

Who is the listed applicant for Trevo Trak 21 Microcatheter?

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

What is the FDA product code for Trevo Trak 21 Microcatheter?

The FDA product code for Trevo Trak 21 Microcatheter is DQO.

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Related Devices (Code: DQO)

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K261455Arterial Pressure Monitoring Set/TraySpectrum VascularK252702Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602NBioptimal International Pte. , Ltd.K254278Arterial Pressure Monitoring Set/TraySpectrum VascularK250751DualView CatheterTerumo CorporationK242966Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterGentuity, LLCK242420pNOVUS 21 MicrocatheterPhenox, Ltd.

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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