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FDA 510(k)

WEDGE PRESSURE CATHETER FLOW DIRECTED

K-Number: K841705 · 1984-07-13

ApplicantMansfield Scientific, Inc.
Decision Date1984-07-13
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WEDGE PRESSURE CATHETER FLOW DIRECTED is the device name listed in this FDA 510(k) record. The listed applicant is Mansfield Scientific, Inc.. It received FDA 510(k) clearance on 1984-07-13 under 510(k) number K841705. 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 FLOW DIRECTED?

WEDGE PRESSURE CATHETER FLOW DIRECTED is a medical device that received FDA 510(k) clearance on 1984-07-13. The listed applicant is Mansfield Scientific, Inc.. The 510(k) number is K841705.

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

WEDGE PRESSURE CATHETER FLOW DIRECTED received FDA 510(k) clearance on 1984-07-13, under 510(k) number K841705.

Who is the listed applicant for WEDGE PRESSURE CATHETER FLOW DIRECTED?

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

What is the FDA product code for WEDGE PRESSURE CATHETER FLOW DIRECTED?

The FDA product code for WEDGE PRESSURE CATHETER FLOW DIRECTED is DYG.

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Other records listing Mansfield Scientific, 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.

K865017ANGIOSCOPEK870186ENDOMYOCARDIAL BIOPSY DEVICEK855103CIRIBART GYUDUBG CATGETERK853850EXPLORERK852797HEPARIN COAT TRAN BALLO TIP TEMP PAC ELECTRODEK851848PERCUTANEOUS TRANSLUMINAL BLOOD DILATION CATHETER

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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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