FDA 510(k)

BACKSTOP VALVE W/SIDE ARM

K-Number: K823190 · 1982-12-30

Decision Date1982-12-30

Product CodeDXT

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

BACKSTOP VALVE W/SIDE ARM is the device name listed in this FDA 510(k) record. The listed applicant is Vertex Medical Corp.. It received FDA 510(k) clearance on 1982-12-30 under 510(k) number K823190. 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 BACKSTOP VALVE W/SIDE ARM?

BACKSTOP VALVE W/SIDE ARM is a medical device that received FDA 510(k) clearance on 1982-12-30. The listed applicant is Vertex Medical Corp.. The 510(k) number is K823190.

When did BACKSTOP VALVE W/SIDE ARM receive FDA 510(k) clearance?

BACKSTOP VALVE W/SIDE ARM received FDA 510(k) clearance on 1982-12-30, under 510(k) number K823190.

Who is the listed applicant for BACKSTOP VALVE W/SIDE ARM?

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

What is the FDA product code for BACKSTOP VALVE W/SIDE ARM?

The FDA product code for BACKSTOP VALVE W/SIDE ARM 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 Vertex Medical Corp. as applicant

K833742ESCHMANN DILATION CATHETER K834476NEPHROSTOMY/BILIARY DRAINAGE BAG K832380PROTECTIVE SLEEVE K831666SIALOGRAPHY NEEDLE K830576LYMPHANGIOGRAPHY SET K830420POLYETHYLENE MONITORING CONNECTORS

View all 21 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 K252653ACIST Pro Diagnostic System (019304); Processing Unit Bed Mount; AngioTouch Module; ACIST Pro Cart; Single Transducer Cable; Triple Transducer CableAcist Medical Systems, Inc.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.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.