Peralta Stone Removal Catheter
K-Number: K190492 · 2019-07-18
ApplicantCalcula Technologies, Inc.
Decision Date2019-07-18
Product CodeFFL
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Peralta Stone Removal Catheter is a medical device manufactured by Calcula Technologies, Inc.. It received FDA 510(k) clearance on 2019-07-18 under approval number K190492. The device is classified under product code FFL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Peralta Stone Removal Catheter?
Peralta Stone Removal Catheter is a medical device that received FDA 510(k) clearance on 2019-07-18. It is manufactured by Calcula Technologies, Inc.. The 510(k) number is K190492.
When was Peralta Stone Removal Catheter approved by the FDA?
Peralta Stone Removal Catheter received FDA 510(k) clearance on 2019-07-18, under approval number K190492.
What company makes Peralta Stone Removal Catheter?
Peralta Stone Removal Catheter is manufactured by Calcula Technologies, Inc..
What is the FDA product code for Peralta Stone Removal Catheter?
The FDA product code for Peralta Stone Removal Catheter is FFL.
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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.