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FDA 510(k)

FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P)

K-Number: K963248 · 1997-02-03

ApplicantJ-Lloyd Medical, Inc.
Decision Date1997-02-03
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P) is the device name listed in this FDA 510(k) record. The listed applicant is J-Lloyd Medical, Inc.. It received FDA 510(k) clearance on 1997-02-03 under 510(k) number K963248. 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 FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P)?

FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P) is a medical device that received FDA 510(k) clearance on 1997-02-03. The listed applicant is J-Lloyd Medical, Inc.. The 510(k) number is K963248.

When did FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P) receive FDA 510(k) clearance?

FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P) received FDA 510(k) clearance on 1997-02-03, under 510(k) number K963248.

Who is the listed applicant for FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P)?

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

What is the FDA product code for FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P)?

The FDA product code for FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P) is DYG.

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Other records listing J-Lloyd 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.

K973639ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC.K971504HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETERK974336CHOLANGIOGRAPH BALLOON CATHETER BY J-LLOYD MEDICAL, INC.K974335EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC.K950440DUAL FUNCTION PACING WEDGE PRESSURE BALLOON CATHETER BY J-LLOYDK940547FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED

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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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