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FDA 510(k)

SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM

K-Number: K050724 · 2005-04-18

ApplicantC.R. Bard, Inc.
Decision Date2005-04-18
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM 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 2005-04-18 under 510(k) number K050724. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM?

SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM is a medical device that received FDA 510(k) clearance on 2005-04-18. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K050724.

When did SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM receive FDA 510(k) clearance?

SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM received FDA 510(k) clearance on 2005-04-18, under 510(k) number K050724.

Who is the listed applicant for SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM?

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 SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM?

The FDA product code for SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM is ITX.

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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.

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