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 a medical device manufactured by Phenox, Ltd.. It received FDA 510(k) clearance on 2022-11-28 under approval 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. It is manufactured by Phenox, Ltd.. The 510(k) number is K221279.
When was pNOVUS 21 Microcatheter approved by the FDA?
pNOVUS 21 Microcatheter received FDA 510(k) clearance on 2022-11-28, under approval number K221279.
What company makes pNOVUS 21 Microcatheter?
pNOVUS 21 Microcatheter is manufactured by Phenox, Ltd..
What is the FDA product code for pNOVUS 21 Microcatheter?
The FDA product code for pNOVUS 21 Microcatheter is DQO.
Other Devices by Phenox, Ltd.
Related Devices (Code: DQO)
K161822Torcon NB Advantage CathetersCook Incorporated
K161287DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-PakMedtronic Vascular
K160662Surefire Infusion SystemSurefire Medical, Inc.
K153125IntraNovo MicrocatheterTexasmedical Technologies, Inc.
K170544Langston dual lumen catheterVascular Solutions, Inc.
K173289Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing CatheterCook Incorporated
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.