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FDA 510(k)

FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm

K-Number: K161967 · 2017-01-27

ApplicantCallisyn Biomedical, Inc.
Decision Date2017-01-27
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm is a medical device manufactured by Callisyn Biomedical, Inc.. It received FDA 510(k) clearance on 2017-01-27 under approval number K161967. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm?

FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm is a medical device that received FDA 510(k) clearance on 2017-01-27. It is manufactured by Callisyn Biomedical, Inc.. The 510(k) number is K161967.

When was FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm approved by the FDA?

FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm received FDA 510(k) clearance on 2017-01-27, under approval number K161967.

What company makes FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm?

FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm is manufactured by Callisyn Biomedical, Inc..

What is the FDA product code for FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm?

The FDA product code for FluidiTube 2.7F Infusion Micro Catheter, 110 cm and 130 cm is KRA.

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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.

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