FDA 510(k)

TUBING, POLYETHYLENE

K-Number: K873597 · 1987-11-12

Decision Date1987-11-12

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

TUBING, POLYETHYLENE is the device name listed in this FDA 510(k) record. The listed applicant is Coeur Laboratories, Inc.. It received FDA 510(k) clearance on 1987-11-12 under 510(k) number K873597. 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 TUBING, POLYETHYLENE?

TUBING, POLYETHYLENE is a medical device that received FDA 510(k) clearance on 1987-11-12. The listed applicant is Coeur Laboratories, Inc.. The 510(k) number is K873597.

When did TUBING, POLYETHYLENE receive FDA 510(k) clearance?

TUBING, POLYETHYLENE received FDA 510(k) clearance on 1987-11-12, under 510(k) number K873597.

Who is the listed applicant for TUBING, POLYETHYLENE?

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

What is the FDA product code for TUBING, POLYETHYLENE?

The FDA product code for TUBING, POLYETHYLENE 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 Coeur Laboratories, Inc. as applicant

K971712COEUR 130 ML ANGIOGRAPHIC SYRINGE K965214COEUR FRONT LOAD INJECTOR RETROFIT KIT (C859-0002)K960965FRONT LOAD INJECTOR TURRET MODEL 859-0001/200 ML FRONT LOAD SYRINGE MODEL 853-0211 K890292PCA-10, 10CC DISP. ANGIOGRAPHY CONTROL SYRINGE K885138CAPILLARY TUBE, BLOOD COLLECTION K88520216 LONG CATHETER W/ADAPTER, 14 FR AND 12 FR

View all 10 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.