FDA 510(k)

FRONT-LOAD POLYPROPYLENE SYRINGE

K-Number: K001663 · 2000-11-16

Decision Date2000-11-16

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

FRONT-LOAD POLYPROPYLENE SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Medrad, Inc.. It received FDA 510(k) clearance on 2000-11-16 under 510(k) number K001663. 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 FRONT-LOAD POLYPROPYLENE SYRINGE?

FRONT-LOAD POLYPROPYLENE SYRINGE is a medical device that received FDA 510(k) clearance on 2000-11-16. The listed applicant is Medrad, Inc.. The 510(k) number is K001663.

When did FRONT-LOAD POLYPROPYLENE SYRINGE receive FDA 510(k) clearance?

FRONT-LOAD POLYPROPYLENE SYRINGE received FDA 510(k) clearance on 2000-11-16, under 510(k) number K001663.

Who is the listed applicant for FRONT-LOAD POLYPROPYLENE SYRINGE?

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 FRONT-LOAD POLYPROPYLENE SYRINGE?

The FDA product code for FRONT-LOAD POLYPROPYLENE SYRINGE 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 Medrad, Inc. as applicant

K130381ANGIOJET ULTRA POWER PULSE KIT K130637JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEM K122916JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEM K113363ANGIOJET SOLENT DISTA THROMBECTOMY SET K113133MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGE K113428ANGIOJET ULTRA DVX THROMBECTOMY SET

View all 104 devices →

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.