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FDA 510(k)

MEDRAD MARK V-PLUS INJECTOR

K-Number: K903390 · 1990-09-26

ApplicantMedrad, Inc.
Decision Date1990-09-26
Product CodeDXT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEDRAD MARK V-PLUS INJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Medrad, Inc.. It received FDA 510(k) clearance on 1990-09-26 under 510(k) number K903390. 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 MARK V-PLUS INJECTOR?

MEDRAD MARK V-PLUS INJECTOR is a medical device that received FDA 510(k) clearance on 1990-09-26. The listed applicant is Medrad, Inc.. The 510(k) number is K903390.

When did MEDRAD MARK V-PLUS INJECTOR receive FDA 510(k) clearance?

MEDRAD MARK V-PLUS INJECTOR received FDA 510(k) clearance on 1990-09-26, under 510(k) number K903390.

Who is the listed applicant for MEDRAD MARK V-PLUS INJECTOR?

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 MARK V-PLUS INJECTOR?

The FDA product code for MEDRAD MARK V-PLUS INJECTOR 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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