FDA 510(k)

WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD

K-Number: K935403 · 1994-05-12

Decision Date1994-05-12

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD 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 1994-05-12 under 510(k) number K935403. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD?

WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD is a medical device that received FDA 510(k) clearance on 1994-05-12. The listed applicant is J-Lloyd Medical, Inc.. The 510(k) number is K935403.

When did WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD receive FDA 510(k) clearance?

WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD received FDA 510(k) clearance on 1994-05-12, under 510(k) number K935403.

Who is the listed applicant for WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD?

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 WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD?

The FDA product code for WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD is DQO.

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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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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.