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FDA 510(k)

FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES)

K-Number: K051519 · 2005-06-21

ApplicantAbbott Laboratories (Perclose, Inc.)
Decision Date2005-06-21
Product CodeLIT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES) is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories (Perclose, Inc.). It received FDA 510(k) clearance on 2005-06-21 under 510(k) number K051519. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES)?

FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES) is a medical device that received FDA 510(k) clearance on 2005-06-21. The listed applicant is Abbott Laboratories (Perclose, Inc.). The 510(k) number is K051519.

When did FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES) receive FDA 510(k) clearance?

FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES) received FDA 510(k) clearance on 2005-06-21, under 510(k) number K051519.

Who is the listed applicant for FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES)?

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

What is the FDA product code for FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES)?

The FDA product code for FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES) is LIT.

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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.

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