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FDA 510(k)

SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS

K-Number: K112407 · 2012-02-09

ApplicantSmiths Medical MD, Inc.
Decision Date2012-02-09
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical MD, Inc.. It received FDA 510(k) clearance on 2012-02-09 under 510(k) number K112407. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS?

SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS is a medical device that received FDA 510(k) clearance on 2012-02-09. The listed applicant is Smiths Medical MD, Inc.. The 510(k) number is K112407.

When did SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS receive FDA 510(k) clearance?

SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS received FDA 510(k) clearance on 2012-02-09, under 510(k) number K112407.

Who is the listed applicant for SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS?

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

What is the FDA product code for SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS?

The FDA product code for SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS is DYB.

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Other records listing Smiths Medical MD, Inc. as applicant

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Related Devices (Code: DYB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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