ER-REBOA Catheter
K-Number: K170411 · 2017-04-04
ApplicantPrytime Medical Devices, Inc.
Decision Date2017-04-04
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
ER-REBOA Catheter is a medical device manufactured by Prytime Medical Devices, Inc.. It received FDA 510(k) clearance on 2017-04-04 under approval number K170411. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ER-REBOA Catheter?
ER-REBOA Catheter is a medical device that received FDA 510(k) clearance on 2017-04-04. It is manufactured by Prytime Medical Devices, Inc.. The 510(k) number is K170411.
When was ER-REBOA Catheter approved by the FDA?
ER-REBOA Catheter received FDA 510(k) clearance on 2017-04-04, under approval number K170411.
What company makes ER-REBOA Catheter?
ER-REBOA Catheter is manufactured by Prytime Medical Devices, Inc..
What is the FDA product code for ER-REBOA Catheter?
The FDA product code for ER-REBOA Catheter is MJN.
Other Devices by Prytime Medical Devices, Inc.
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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.