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FDA 510(k)

IntelliCartTM System

K-Number: K162421 · 2016-12-21

ApplicantDornoch Medical Systems
Decision Date2016-12-21
Product CodeJCX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IntelliCartTM System is the device name listed in this FDA 510(k) record. The listed applicant is Dornoch Medical Systems. It received FDA 510(k) clearance on 2016-12-21 under 510(k) number K162421. The device is classified under product code JCX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IntelliCartTM System?

IntelliCartTM System is a medical device that received FDA 510(k) clearance on 2016-12-21. The listed applicant is Dornoch Medical Systems. The 510(k) number is K162421.

When did IntelliCartTM System receive FDA 510(k) clearance?

IntelliCartTM System received FDA 510(k) clearance on 2016-12-21, under 510(k) number K162421.

Who is the listed applicant for IntelliCartTM System?

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

What is the FDA product code for IntelliCartTM System?

The FDA product code for IntelliCartTM System is JCX.

Other records listing Dornoch Medical Systems as applicant

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.

K190789IntelliCartTM SystemK172481IntelliCart System

Related Devices (Code: JCX)

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.

K250964Protable Phlegm Suction Unit (JMA D01)Jiangsu Jumao X-Care Medical Equipment Co., Ltd.K243638MV Flow Aspiration Pump (MVFLOWPMP01)MicroventionK251111CaryExcitus ASK243418Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate TubingMicro Therapeutics, Inc. d/b/a ev3 NeurovascularK233428Easycess Aspiration PumpGuangzhou Easycess Medical Co.,LtdK222552120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000)Stryker Instruments

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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