FDA 510(k)

7FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVE

K-Number: K910987 · 1991-05-29

ApplicantScimed

Decision Date1991-05-29

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

7FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVE is the device name listed in this FDA 510(k) record. The listed applicant is Scimed. It received FDA 510(k) clearance on 1991-05-29 under 510(k) number K910987. 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 7FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVE?

7FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVE is a medical device that received FDA 510(k) clearance on 1991-05-29. The listed applicant is Scimed. The 510(k) number is K910987.

When did 7FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVE receive FDA 510(k) clearance?

7FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVE received FDA 510(k) clearance on 1991-05-29, under 510(k) number K910987.

Who is the listed applicant for 7FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVE?

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

What is the FDA product code for 7FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVE?

The FDA product code for 7FR. AND 8FR. TRIGUIDE GUIDING CATHETER ADD. CURVE 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.