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FDA 510(k)

ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS

K-Number: K070798 · 2007-10-04

ApplicantCoeur, Inc.
Decision Date2007-10-04
Product CodeDXT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS is the device name listed in this FDA 510(k) record. The listed applicant is Coeur, Inc.. It received FDA 510(k) clearance on 2007-10-04 under 510(k) number K070798. 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 ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS?

ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS is a medical device that received FDA 510(k) clearance on 2007-10-04. The listed applicant is Coeur, Inc.. The 510(k) number is K070798.

When did ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS receive FDA 510(k) clearance?

ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS received FDA 510(k) clearance on 2007-10-04, under 510(k) number K070798.

Who is the listed applicant for ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS?

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

What is the FDA product code for ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS?

The FDA product code for ADAPTERS FOR CT, ANGIOGRAPHIC, AND/OR MRI POWER INJECTORS is DXT.

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Other records listing Coeur, Inc. 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.

K170431CT Syringe for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), CT Syringe Dual Pack for Stellant Injectors (with & without Spikes, Prime Tubes, & Fill Tubes), Single Fascia and Ram Tip, Dual Fascia and Ram TipK161471MR Syringe Dual Pack for Solaris InjectorsK120892DISPOSABLE 330PSI EXTENSION LINESK113498DISPOSABLE TORQUE DEVICEK113132DISPOSABLE HEMOSTATIC Y-CONNECTORSK090487DISPOSABLE ANGIOGRAPHIC SYRINGES FOR USE WITH NEMOTO ANGIOGRAPHIC POWER, MODEL SY-125, C855-5150

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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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