FDA 510(k)

SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60)

K-Number: K955534 · 1996-08-01

ApplicantInternational Innovations, Inc.

Decision Date1996-08-01

Product CodeKRA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60) is the device name listed in this FDA 510(k) record. The listed applicant is International Innovations, Inc.. It received FDA 510(k) clearance on 1996-08-01 under 510(k) number K955534. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60)?

SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60) is a medical device that received FDA 510(k) clearance on 1996-08-01. The listed applicant is International Innovations, Inc.. The 510(k) number is K955534.

When did SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60) receive FDA 510(k) clearance?

SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60) received FDA 510(k) clearance on 1996-08-01, under 510(k) number K955534.

Who is the listed applicant for SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60)?

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

What is the FDA product code for SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60)?

The FDA product code for SEQUE INFUSION CATHETER (S-25,30,35,40,45,50,60) is KRA.

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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.