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FDA 510(k)

MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC

K-Number: K082905 · 2009-01-12

ApplicantMedrad, Inc.
Decision Date2009-01-12
Product CodeDXT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC is the device name listed in this FDA 510(k) record. The listed applicant is Medrad, Inc.. It received FDA 510(k) clearance on 2009-01-12 under 510(k) number K082905. 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 MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC?

MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC is a medical device that received FDA 510(k) clearance on 2009-01-12. The listed applicant is Medrad, Inc.. The 510(k) number is K082905.

When did MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC receive FDA 510(k) clearance?

MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC received FDA 510(k) clearance on 2009-01-12, under 510(k) number K082905.

Who is the listed applicant for MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC?

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

What is the FDA product code for MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC?

The FDA product code for MEDRAD STELLANT CT INJECTOR SYSTEM WITH P3T CARDIAC is DXT.

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Other records listing Medrad, Inc. as applicant

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K130381ANGIOJET ULTRA POWER PULSE KITK130637JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEMK122916JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEMK113363ANGIOJET SOLENT DISTA THROMBECTOMY SETK113133MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGEK113428ANGIOJET ULTRA DVX THROMBECTOMY SET

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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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