Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PCI W/CATH-SEAL SIDE FLOW FITTING

K-Number: K842259 · 1984-08-01

ApplicantUniversal Medical Instrument Corp.
Decision Date1984-08-01
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PCI W/CATH-SEAL SIDE FLOW FITTING is the device name listed in this FDA 510(k) record. The listed applicant is Universal Medical Instrument Corp.. It received FDA 510(k) clearance on 1984-08-01 under 510(k) number K842259. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PCI W/CATH-SEAL SIDE FLOW FITTING?

PCI W/CATH-SEAL SIDE FLOW FITTING is a medical device that received FDA 510(k) clearance on 1984-08-01. The listed applicant is Universal Medical Instrument Corp.. The 510(k) number is K842259.

When did PCI W/CATH-SEAL SIDE FLOW FITTING receive FDA 510(k) clearance?

PCI W/CATH-SEAL SIDE FLOW FITTING received FDA 510(k) clearance on 1984-08-01, under 510(k) number K842259.

Who is the listed applicant for PCI W/CATH-SEAL SIDE FLOW FITTING?

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

What is the FDA product code for PCI W/CATH-SEAL SIDE FLOW FITTING?

The FDA product code for PCI W/CATH-SEAL SIDE FLOW FITTING is DYB.

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_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Universal Medical Instrument Corp. 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.

K962180CATH SEALK935077CATH-SEALK897128UMI BRAIDED CATHETER CONNECTORK881796UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLEK863178UMI STEERABLE TORQUE GUIDE WIREK861984UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO

View all 21 devices →

Related Devices (Code: DYB)

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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.

↑