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)

SWAN-GANZ VIP-CATHETER

K-Number: K820222 · 1982-02-12

ApplicantAmerican Edwards Laboratories
Decision Date1982-02-12
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SWAN-GANZ VIP-CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is American Edwards Laboratories. It received FDA 510(k) clearance on 1982-02-12 under 510(k) number K820222. 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 SWAN-GANZ VIP-CATHETER?

SWAN-GANZ VIP-CATHETER is a medical device that received FDA 510(k) clearance on 1982-02-12. The listed applicant is American Edwards Laboratories. The 510(k) number is K820222.

When did SWAN-GANZ VIP-CATHETER receive FDA 510(k) clearance?

SWAN-GANZ VIP-CATHETER received FDA 510(k) clearance on 1982-02-12, under 510(k) number K820222.

Who is the listed applicant for SWAN-GANZ VIP-CATHETER?

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

What is the FDA product code for SWAN-GANZ VIP-CATHETER?

The FDA product code for SWAN-GANZ VIP-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 American Edwards Laboratories 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.

K873485EDSLAB (R) OCCLUSION BALLOON CATHETERK872596TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30K872529THERMODILUTION CARDIAC OUTPUT COMPUTER, MOD. COM-2K870444HOMEPRO II VOLUMETRIC INFUSION PUMPK864997MEDTRAC VP VOLUMETRIC INFUSION PUMPK864330SHEAR FORCE GAUGE

View all 89 devices →

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.

↑