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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 the device name listed in this FDA 510(k) record. The listed applicant is Kalera Medical, Inc.. It received FDA 510(k) clearance on 2020-05-22 under 510(k) 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. The listed applicant is Kalera Medical, Inc.. The 510(k) number is K200419.

When did Kalera Vacuum Aspiration Catheter (K-VAC) receive FDA 510(k) clearance?

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

Who is the listed applicant for Kalera Vacuum Aspiration Catheter (K-VAC)?

The FDA 510(k) record lists Kalera Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Devices (Code: FED)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260965CVAC Aspiration SystemCalyxo, Inc.K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)Zhuhai Pusen Medical Technology Co., Ltd.K252572Prodeon Urethral Sheath SystemProdeon Medical, Inc.K250128Single Use Suction-Evacuation Ureteral Access SheathAnhui Happiness Workshop Medical Instruments Co., Ltd.K250132Ureteral Access SheathZhejiang YiGao Medical Technology Co., Ltd.K250695Single-use Ureteral Access SheathShenzhen HugeMed Medical Technical Development Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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