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FDA 510(k)

SILICONE FLOW-DIRECTED THERMODILUTION CATHETER

K-Number: K893435 · 1989-09-26

ApplicantCathlab Corp.
Decision Date1989-09-26
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SILICONE FLOW-DIRECTED THERMODILUTION CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Cathlab Corp.. It received FDA 510(k) clearance on 1989-09-26 under 510(k) number K893435. 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 SILICONE FLOW-DIRECTED THERMODILUTION CATHETER?

SILICONE FLOW-DIRECTED THERMODILUTION CATHETER is a medical device that received FDA 510(k) clearance on 1989-09-26. The listed applicant is Cathlab Corp.. The 510(k) number is K893435.

When did SILICONE FLOW-DIRECTED THERMODILUTION CATHETER receive FDA 510(k) clearance?

SILICONE FLOW-DIRECTED THERMODILUTION CATHETER received FDA 510(k) clearance on 1989-09-26, under 510(k) number K893435.

Who is the listed applicant for SILICONE FLOW-DIRECTED THERMODILUTION CATHETER?

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

What is the FDA product code for SILICONE FLOW-DIRECTED THERMODILUTION CATHETER?

The FDA product code for SILICONE FLOW-DIRECTED THERMODILUTION CATHETER is DYG.

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Other records listing Cathlab Corp. 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.

K910917CATHLAB SILICONE BILIARY BALLOON CATHETERK910916CATHLAB SILICONE OCCLUSION BALLOON CATHETERK905139CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETERK897051MILLER PERCUTANEOUS ANGIOGRAPHIC/SCOPIC IRRI. CATHK8971843F AND 4F IRRIGATION EMBOLECTOMY CATHETERSK893680SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH.

View all 8 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.

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