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FDA 510(k)

pNOVUS 21 Microcatheter

K-Number: K221279 · 2022-11-28

ApplicantPhenox, Ltd.
Decision Date2022-11-28
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

pNOVUS 21 Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Phenox, Ltd.. It received FDA 510(k) clearance on 2022-11-28 under 510(k) number K221279. 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 pNOVUS 21 Microcatheter?

pNOVUS 21 Microcatheter is a medical device that received FDA 510(k) clearance on 2022-11-28. The listed applicant is Phenox, Ltd.. The 510(k) number is K221279.

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

pNOVUS 21 Microcatheter received FDA 510(k) clearance on 2022-11-28, under 510(k) number K221279.

Who is the listed applicant for pNOVUS 21 Microcatheter?

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

What is the FDA product code for pNOVUS 21 Microcatheter?

The FDA product code for pNOVUS 21 Microcatheter is DQO.

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.

NCT07143019The Use of p48/64 MW HPC Flow Modulation Device in the Treatment of Wide-necked Intracranial AneurysmsRECRUITINGNCT07748572PMCF Registry to Describe the Safety and Performance of p64, p48 MW and p64 MW in FranceRECRUITING

Other records listing Phenox, Ltd. 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.

K251357Esperance pHLO Aspiration SystemK242676pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy DeviceK242420pNOVUS 21 MicrocatheterK231539pRESET LITE Thrombectomy DeviceK222848pRESET Thrombectomy DeviceK191687pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire

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Related Devices (Code: DQO)

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.

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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