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FDA 510(k)

OPTISTAR ELITE INJECTION SYSTEM

K-Number: K073592 · 2008-05-07

ApplicantMallinckrodt Inc., Liebel-Flarsheim Business
Decision Date2008-05-07
Product CodeDXT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OPTISTAR ELITE 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 2008-05-07 under 510(k) number K073592. 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 OPTISTAR ELITE INJECTION SYSTEM?

OPTISTAR ELITE INJECTION SYSTEM is a medical device that received FDA 510(k) clearance on 2008-05-07. The listed applicant is Mallinckrodt Inc., Liebel-Flarsheim Business. The 510(k) number is K073592.

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

OPTISTAR ELITE INJECTION SYSTEM received FDA 510(k) clearance on 2008-05-07, under 510(k) number K073592.

Who is the listed applicant for OPTISTAR ELITE 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 OPTISTAR ELITE INJECTION SYSTEM?

The FDA product code for OPTISTAR ELITE INJECTION SYSTEM is DXT.

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

K082212SYRINGE WITH HANDI-FILK063503OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATIONK042744OPTIV ANTAGE DH POWER INJECTION SYSTEMK031339OPTIBOLUSK022116ELPH INJECTION SYSTEMK984088OPTISTAR MR INJECTOR SYSTEM

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Related Devices (Code: DXT)

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.

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 LimitedK252638VeraPro 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.

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