FDA 510(k)

CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000

K-Number: K101261 · 2010-07-29

Decision Date2010-07-29

Product CodeNFK

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2010-07-29 under 510(k) number K101261. The device is classified under product code NFK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000?

CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 is a medical device that received FDA 510(k) clearance on 2010-07-29. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K101261.

When did CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 receive FDA 510(k) clearance?

CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 received FDA 510(k) clearance on 2010-07-29, under 510(k) number K101261.

Who is the listed applicant for CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000?

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

What is the FDA product code for CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000?

The FDA product code for CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 is NFK.

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Related Devices (Code: NFK)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.