FDA 510(k)

ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH

K-Number: K993774 · 1999-12-07

Decision Date1999-12-07

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH is the device name listed in this FDA 510(k) record. The listed applicant is Acist Medical Systems. It received FDA 510(k) clearance on 1999-12-07 under 510(k) number K993774. 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 ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH?

ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH is a medical device that received FDA 510(k) clearance on 1999-12-07. The listed applicant is Acist Medical Systems. The 510(k) number is K993774.

When did ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH receive FDA 510(k) clearance?

ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH received FDA 510(k) clearance on 1999-12-07, under 510(k) number K993774.

Who is the listed applicant for ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH?

The FDA 510(k) record lists Acist Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH?

The FDA product code for ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL CL1OOH is DXT.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Acist Medical Systems as applicant

K020892ACIST GENTOO CONTRAST INJECTION SYSTEM K021015ACIST PLUS 4 ANGIOGRAPHIC CATHETER K991103MODIFICATION TO ACIST CL 100H K000013ACIST ANGIOGRAPHIC INJECTION SYSTEM, MODEL R-2000 K984058ACIST INJECTOR SYSTEM, MODEL CL100 H

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.