Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Bendit2.7 Steerable Microcatheter

K-Number: K190126 · 2019-08-22

Decision Date2019-08-22
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Bendit2.7 Steerable Microcatheter is a medical device manufactured by Bend IT Technologies, Ltd.. It received FDA 510(k) clearance on 2019-08-22 under approval number K190126. 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 Bendit2.7 Steerable Microcatheter?

Bendit2.7 Steerable Microcatheter is a medical device that received FDA 510(k) clearance on 2019-08-22. It is manufactured by Bend IT Technologies, Ltd.. The 510(k) number is K190126.

When was Bendit2.7 Steerable Microcatheter approved by the FDA?

Bendit2.7 Steerable Microcatheter received FDA 510(k) clearance on 2019-08-22, under approval number K190126.

What company makes Bendit2.7 Steerable Microcatheter?

Bendit2.7 Steerable Microcatheter is manufactured by Bend IT Technologies, Ltd..

What is the FDA product code for Bendit2.7 Steerable Microcatheter?

The FDA product code for Bendit2.7 Steerable Microcatheter is DQO.

Other Devices by Bend IT Technologies, Ltd.

Related Devices (Code: DQO)

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.