FDA 510(k)

ELPH INJECTION SYSTEM

K-Number: K022116 · 2002-07-26

ApplicantMallinckrodt Inc., Liebel-Flarsheim Business

Decision Date2002-07-26

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ELPH INJECTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Inc., Liebel-Flarsheim Business. It received FDA 510(k) clearance on 2002-07-26 under 510(k) number K022116. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELPH INJECTION SYSTEM?

ELPH INJECTION SYSTEM is a medical device that received FDA 510(k) clearance on 2002-07-26. The listed applicant is Mallinckrodt Inc., Liebel-Flarsheim Business. The 510(k) number is K022116.

When did ELPH INJECTION SYSTEM receive FDA 510(k) clearance?

ELPH INJECTION SYSTEM received FDA 510(k) clearance on 2002-07-26, under 510(k) number K022116.

Who is the listed applicant for ELPH INJECTION SYSTEM?

The FDA 510(k) record lists Mallinckrodt Inc., Liebel-Flarsheim Business as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ELPH INJECTION SYSTEM?

The FDA product code for ELPH INJECTION SYSTEM is DXT.

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Other records listing Mallinckrodt Inc., Liebel-Flarsheim Business as applicant

K082212SYRINGE WITH HANDI-FIL K073592OPTISTAR ELITE INJECTION SYSTEM K063503OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION K042744OPTIV ANTAGE DH POWER INJECTION SYSTEM K031339OPTIBOLUS K984088OPTISTAR MR INJECTOR SYSTEM

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Related Devices (Code: DXT)

K252652Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable SyrFortis Biosolutions Company Limited K252638VeraPro S100 Multi-Use Syringe (018808); VeraPro S100 LV1 Low Viscosity Single-Use Syringe (018811); VeraPro AMT Auto-Manifold and Transducer (018814); VeraPro AngioTouch FLX165 Hand Controller Kit (018806); VeraPro AngioTouch HiFi165 Hand Controller Kit (018804)Acist Medical Systems, Inc.K252653ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer CableAcist Medical Systems, Inc.K253048High Pressure Syringe; Pressure Connecting Tube; Quick fill tube; Spike; Transfer TubeShenzhen Maiwei Biotech Co., Ltd.K251788Extension tubeZhuhai DR Medical Instruments Co., Ltd.K252891MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD ISI2 Module (ISI2)Bayer Medical Care, Inc.

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.