ER-REBOA PLUS Catheter
K-Number: K193440 · 2020-01-09
ApplicantPrytime Medical Devices, Inc.
Decision Date2020-01-09
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
ER-REBOA PLUS Catheter is a medical device manufactured by Prytime Medical Devices, Inc.. It received FDA 510(k) clearance on 2020-01-09 under approval number K193440. 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 PLUS Catheter?
ER-REBOA PLUS Catheter is a medical device that received FDA 510(k) clearance on 2020-01-09. It is manufactured by Prytime Medical Devices, Inc.. The 510(k) number is K193440.
When was ER-REBOA PLUS Catheter approved by the FDA?
ER-REBOA PLUS Catheter received FDA 510(k) clearance on 2020-01-09, under approval number K193440.
What company makes ER-REBOA PLUS Catheter?
ER-REBOA PLUS Catheter is manufactured by Prytime Medical Devices, Inc..
What is the FDA product code for ER-REBOA PLUS Catheter?
The FDA product code for ER-REBOA PLUS Catheter is MJN.
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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.