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FDA 510(k)

BALLOON WEDGE PRESSURE CATHETER

K-Number: K822034 · 1982-08-24

ApplicantZiehm International, Inc.
Decision Date1982-08-24
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BALLOON WEDGE PRESSURE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Ziehm International, Inc.. It received FDA 510(k) clearance on 1982-08-24 under 510(k) number K822034. 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 BALLOON WEDGE PRESSURE CATHETER?

BALLOON WEDGE PRESSURE CATHETER is a medical device that received FDA 510(k) clearance on 1982-08-24. The listed applicant is Ziehm International, Inc.. The 510(k) number is K822034.

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

BALLOON WEDGE PRESSURE CATHETER received FDA 510(k) clearance on 1982-08-24, under 510(k) number K822034.

Who is the listed applicant for BALLOON WEDGE PRESSURE CATHETER?

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

What is the FDA product code for BALLOON WEDGE PRESSURE CATHETER?

The FDA product code for BALLOON WEDGE PRESSURE CATHETER is DYG.

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Other records listing Ziehm International, 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.

K011292ZIEHM VISIONK910455IMS DISPOSABLE HOLDER WITH NEEDLE RETRACTORK902196MODIFIED STICK-GARD SAFETY NEEDLEK894021MOBILE X-RAY UNITK894041PUMP-JECT SYRINGE WITH LUER-LOCKK890620STICK-GARD SAFETY NEEDLE

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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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