FDA 510(k)

CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510; WIRE, GUIDE, CATHETER, MODEL QSW1000

K-Number: K994141 · 2000-07-21

Decision Date2000-07-21

Product CodeMJN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510; WIRE, GUIDE, CATHETER, MODEL QSW1000 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Ave, Inc.. It received FDA 510(k) clearance on 2000-07-21 under 510(k) number K994141. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510; WIRE, GUIDE, CATHETER, MODEL QSW1000?

CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510; WIRE, GUIDE, CATHETER, MODEL QSW1000 is a medical device that received FDA 510(k) clearance on 2000-07-21. The listed applicant is Medtronic Ave, Inc.. The 510(k) number is K994141.

When did CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510; WIRE, GUIDE, CATHETER, MODEL QSW1000 receive FDA 510(k) clearance?

CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510; WIRE, GUIDE, CATHETER, MODEL QSW1000 received FDA 510(k) clearance on 2000-07-21, under 510(k) number K994141.

Who is the listed applicant for CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510; WIRE, GUIDE, CATHETER, MODEL QSW1000?

The FDA 510(k) record lists Medtronic Ave, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510; WIRE, GUIDE, CATHETER, MODEL QSW1000?

The FDA product code for CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, MODEL SOL 3510; WIRE, GUIDE, CATHETER, MODEL QSW1000 is MJN.

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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.