Cronus HP - High Pressure Peripheral Balloon Catheter
K-Number: K151141 · 2016-01-14
ApplicantNipro Medical Corporation
Decision Date2016-01-14
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Cronus HP - High Pressure Peripheral Balloon Catheter is a medical device manufactured by Nipro Medical Corporation. It received FDA 510(k) clearance on 2016-01-14 under approval number K151141. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Cronus HP - High Pressure Peripheral Balloon Catheter?
Cronus HP - High Pressure Peripheral Balloon Catheter is a medical device that received FDA 510(k) clearance on 2016-01-14. It is manufactured by Nipro Medical Corporation. The 510(k) number is K151141.
When was Cronus HP - High Pressure Peripheral Balloon Catheter approved by the FDA?
Cronus HP - High Pressure Peripheral Balloon Catheter received FDA 510(k) clearance on 2016-01-14, under approval number K151141.
What company makes Cronus HP - High Pressure Peripheral Balloon Catheter?
Cronus HP - High Pressure Peripheral Balloon Catheter is manufactured by Nipro Medical Corporation.
What is the FDA product code for Cronus HP - High Pressure Peripheral Balloon Catheter?
The FDA product code for Cronus HP - High Pressure Peripheral Balloon Catheter is LIT.
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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.