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FDA 510(k)

INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER

K-Number: K911840 · 1991-06-03

ApplicantIntec Medical, Inc.
Decision Date1991-06-03
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Intec Medical, Inc.. It received FDA 510(k) clearance on 1991-06-03 under 510(k) number K911840. 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 INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER?

INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER is a medical device that received FDA 510(k) clearance on 1991-06-03. The listed applicant is Intec Medical, Inc.. The 510(k) number is K911840.

When did INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER receive FDA 510(k) clearance?

INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER received FDA 510(k) clearance on 1991-06-03, under 510(k) number K911840.

Who is the listed applicant for INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER?

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

What is the FDA product code for INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER?

The FDA product code for INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER is DYG.

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Other records listing Intec Medical, 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.

K903216THE GUIDER CORONARY GUIDING CATHETERK903217TAPERED TIP THE GUIDER CORONARY GUIDING CATHETERK900710INTERFLO MEDICAL MODEL F-1 THERMODILUTION CATHETERK903840GIANT LUMEN SAFETIP SERIES: ENDOMYOCARDIAL BIOPSYK903906PERCUTANEOUS CATHETER INTRODUCER KITK900998INTERVENTIONAL MEDICAL Y ADAPTER W/ADJUST. VALVE

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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.

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