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FDA 510(k)

PRUITT ARTERIAL OCCLUSION CHOLANG. CATH

K-Number: K812111 · 1981-11-16

ApplicantBionomy, Inc.
Decision Date1981-11-16
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PRUITT ARTERIAL OCCLUSION CHOLANG. CATH is the device name listed in this FDA 510(k) record. The listed applicant is Bionomy, Inc.. It received FDA 510(k) clearance on 1981-11-16 under 510(k) number K812111. 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 PRUITT ARTERIAL OCCLUSION CHOLANG. CATH?

PRUITT ARTERIAL OCCLUSION CHOLANG. CATH is a medical device that received FDA 510(k) clearance on 1981-11-16. The listed applicant is Bionomy, Inc.. The 510(k) number is K812111.

When did PRUITT ARTERIAL OCCLUSION CHOLANG. CATH receive FDA 510(k) clearance?

PRUITT ARTERIAL OCCLUSION CHOLANG. CATH received FDA 510(k) clearance on 1981-11-16, under 510(k) number K812111.

Who is the listed applicant for PRUITT ARTERIAL OCCLUSION CHOLANG. CATH?

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

What is the FDA product code for PRUITT ARTERIAL OCCLUSION CHOLANG. CATH?

The FDA product code for PRUITT ARTERIAL OCCLUSION CHOLANG. CATH 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.

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Other records listing Bionomy, 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.

K851101BIONOMY'S MULTI-LUMEN CENTRAL VENOUS CATHETER-SETK844094PRUITT IRRIGATION AND OCCLUSION CATHETERK832023EMBOLECTOMY CATHETERK811276OCCLUSION 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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