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FDA 510(k)

Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site

K-Number: K170897 · 2017-11-03

ApplicantB.Braun Medical, Inc.
Decision Date2017-11-03
Product CodePTI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2017-11-03 under 510(k) number K170897. The device is classified under product code PTI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site?

Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site is a medical device that received FDA 510(k) clearance on 2017-11-03. The listed applicant is B.Braun Medical, Inc.. The 510(k) number is K170897.

When did Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site receive FDA 510(k) clearance?

Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site received FDA 510(k) clearance on 2017-11-03, under 510(k) number K170897.

Who is the listed applicant for Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site?

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

What is the FDA product code for Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site?

The FDA product code for Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site is PTI.

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Related Devices (Code: PTI)

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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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