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FDA 510(k)

EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC.

K-Number: K974335 · 1998-02-13

ApplicantJ-Lloyd Medical, Inc.
Decision Date1998-02-13
Product CodeDXE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC. 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 1998-02-13 under 510(k) number K974335. The device is classified under product code DXE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC.?

EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC. is a medical device that received FDA 510(k) clearance on 1998-02-13. The listed applicant is J-Lloyd Medical, Inc.. The 510(k) number is K974335.

When did EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC. receive FDA 510(k) clearance?

EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC. received FDA 510(k) clearance on 1998-02-13, under 510(k) number K974335.

Who is the listed applicant for EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC.?

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 EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC.?

The FDA product code for EMBOLECTOMY, IRRIGATION - OCCLUSION BALLOON CATHETER BY J-LLOYD MEDICAL, INC. is DXE.

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

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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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