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FDA 510(k)

Kalera Vacuum Aspiration Catheter (K-VAC)

K-Number: K200419 · 2020-05-22

ApplicantKalera Medical, Inc.
Decision Date2020-05-22
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Kalera Vacuum Aspiration Catheter (K-VAC) is a medical device manufactured by Kalera Medical, Inc.. It received FDA 510(k) clearance on 2020-05-22 under approval number K200419. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kalera Vacuum Aspiration Catheter (K-VAC)?

Kalera Vacuum Aspiration Catheter (K-VAC) is a medical device that received FDA 510(k) clearance on 2020-05-22. It is manufactured by Kalera Medical, Inc.. The 510(k) number is K200419.

When was Kalera Vacuum Aspiration Catheter (K-VAC) approved by the FDA?

Kalera Vacuum Aspiration Catheter (K-VAC) received FDA 510(k) clearance on 2020-05-22, under approval number K200419.

What company makes Kalera Vacuum Aspiration Catheter (K-VAC)?

Kalera Vacuum Aspiration Catheter (K-VAC) is manufactured by Kalera Medical, Inc..

What is the FDA product code for Kalera Vacuum Aspiration Catheter (K-VAC)?

The FDA product code for Kalera Vacuum Aspiration Catheter (K-VAC) is FED.

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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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