FDA 510(k)

ICATH, STERILESURE

K-Number: K071496 · 2007-08-15

ApplicantColorado Catheter Company, Inc.

Decision Date2007-08-15

Product CodeNWO

Advisory CommitteeGU

DecisionUnknown

Device Summary

ICATH, STERILESURE is the device name listed in this FDA 510(k) record. The listed applicant is Colorado Catheter Company, Inc.. It received FDA 510(k) clearance on 2007-08-15 under 510(k) number K071496. The device is classified under product code NWO. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the ICATH, STERILESURE?

ICATH, STERILESURE is a medical device that received FDA 510(k) clearance on 2007-08-15. The listed applicant is Colorado Catheter Company, Inc.. The 510(k) number is K071496.

When did ICATH, STERILESURE receive FDA 510(k) clearance?

ICATH, STERILESURE received FDA 510(k) clearance on 2007-08-15, under 510(k) number K071496.

Who is the listed applicant for ICATH, STERILESURE?

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

What is the FDA product code for ICATH, STERILESURE?

The FDA product code for ICATH, STERILESURE is NWO.

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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.