FDA 510(k)

MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS

K-Number: K000956 · 2000-04-21

Decision Date2000-04-21

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Scimed, Inc.. It received FDA 510(k) clearance on 2000-04-21 under 510(k) number K000956. 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 MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS?

MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS is a medical device that received FDA 510(k) clearance on 2000-04-21. The listed applicant is Boston Scientific Scimed, Inc.. The 510(k) number is K000956.

When did MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS receive FDA 510(k) clearance?

MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS received FDA 510(k) clearance on 2000-04-21, under 510(k) number K000956.

Who is the listed applicant for MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS?

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

What is the FDA product code for MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS?

The FDA product code for MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS is DQO.

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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.