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FDA 510(k)

SAPIENS TIP CONFIRMATION SYSTEM

K-Number: K112744 · 2011-10-20

ApplicantC.R. Bard, Inc.
Decision Date2011-10-20
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SAPIENS TIP CONFIRMATION 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 2011-10-20 under 510(k) number K112744. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAPIENS TIP CONFIRMATION SYSTEM?

SAPIENS TIP CONFIRMATION SYSTEM is a medical device that received FDA 510(k) clearance on 2011-10-20. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K112744.

When did SAPIENS TIP CONFIRMATION SYSTEM receive FDA 510(k) clearance?

SAPIENS TIP CONFIRMATION SYSTEM received FDA 510(k) clearance on 2011-10-20, under 510(k) number K112744.

Who is the listed applicant for SAPIENS TIP CONFIRMATION 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 SAPIENS TIP CONFIRMATION SYSTEM?

The FDA product code for SAPIENS TIP CONFIRMATION SYSTEM is LJS.

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Related Devices (Code: LJS)

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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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