FDA 510(k)

FETCH 2 ASPIRATION CATHETER MODEL 109400-001

K-Number: K101354 · 2011-01-21

Decision Date2011-01-21

Product CodeQEZ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

FETCH 2 ASPIRATION CATHETER MODEL 109400-001 is the device name listed in this FDA 510(k) record. The listed applicant is Medrad Interventional/Possis. It received FDA 510(k) clearance on 2011-01-21 under 510(k) number K101354. The device is classified under product code QEZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FETCH 2 ASPIRATION CATHETER MODEL 109400-001?

FETCH 2 ASPIRATION CATHETER MODEL 109400-001 is a medical device that received FDA 510(k) clearance on 2011-01-21. The listed applicant is Medrad Interventional/Possis. The 510(k) number is K101354.

When did FETCH 2 ASPIRATION CATHETER MODEL 109400-001 receive FDA 510(k) clearance?

FETCH 2 ASPIRATION CATHETER MODEL 109400-001 received FDA 510(k) clearance on 2011-01-21, under 510(k) number K101354.

Who is the listed applicant for FETCH 2 ASPIRATION CATHETER MODEL 109400-001?

The FDA 510(k) record lists Medrad Interventional/Possis as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FETCH 2 ASPIRATION CATHETER MODEL 109400-001?

The FDA product code for FETCH 2 ASPIRATION CATHETER MODEL 109400-001 is QEZ.

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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.