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)

WEDGE PRESSURE CATHETER

K-Number: K830604 · 1983-07-18

ApplicantPlasmedics, Inc.
Decision Date1983-07-18
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WEDGE PRESSURE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Plasmedics, Inc.. It received FDA 510(k) clearance on 1983-07-18 under 510(k) number K830604. The device is classified under product code DYG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WEDGE PRESSURE CATHETER?

WEDGE PRESSURE CATHETER is a medical device that received FDA 510(k) clearance on 1983-07-18. The listed applicant is Plasmedics, Inc.. The 510(k) number is K830604.

When did WEDGE PRESSURE CATHETER receive FDA 510(k) clearance?

WEDGE PRESSURE CATHETER received FDA 510(k) clearance on 1983-07-18, under 510(k) number K830604.

Who is the listed applicant for WEDGE PRESSURE CATHETER?

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

What is the FDA product code for WEDGE PRESSURE CATHETER?

The FDA product code for WEDGE PRESSURE CATHETER is DYG.

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 Plasmedics, Inc. 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.

K853559STERILE BIOPSY NEEDLESK850263PEDIATRIC ANESTHESIA MASK W/PACIFIER/RING ASSEMBLYK831601APNEA ALARM FOR ADULT-PEDIATRIC & NEONK831650ANESTHESIA/RESPIRATORY DISCONNECT -K823351CENTRAL VENOUS CATHETER

Related Devices (Code: DYG)

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.

K242451HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)Edwards LifesciencesK233983Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)Edwards LifesciencesK233824Swan-Ganz catheterEdwards Lifesciences, LLCK231248Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring PlatformEdwards Lifesciencess, LLCK222117Swang-Ganz IQ pulmonary artery catheterEdwards Lifesiences, LLCK193466Swan-Ganz CathetersEdwards Lifesciences, 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.

↑