FDA 510(k)

FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED

K-Number: K940547 · 1994-08-11

Decision Date1994-08-11

Product CodeDYG

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED 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 1994-08-11 under 510(k) number K940547. 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 DIRECT THERMODILUT BALLOON CATH HEPARIN COATED?

FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED is a medical device that received FDA 510(k) clearance on 1994-08-11. The listed applicant is J-Lloyd Medical, Inc.. The 510(k) number is K940547.

When did FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED receive FDA 510(k) clearance?

FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED received FDA 510(k) clearance on 1994-08-11, under 510(k) number K940547.

Who is the listed applicant for FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED?

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 DIRECT THERMODILUT BALLOON CATH HEPARIN COATED?

The FDA product code for FLOW DIRECT THERMODILUT BALLOON CATH HEPARIN COATED is DYG.

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Other records listing J-Lloyd Medical, Inc. as applicant

K971504HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER K973639ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC.K974336CHOLANGIOGRAPH BALLOON CATHETER BY J-LLOYD MEDICAL, INC.K974335EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC.K963248FLOW DIRECTED THERMODILUTION/INFUSION BALLOON CATHETER (575-110P)K950440DUAL FUNCTION PACING WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD

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Related Devices (Code: DYG)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.