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FDA 510(k)

LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM

K-Number: K111603 · 2012-08-23

ApplicantEp Dynamics, Inc.
Decision Date2012-08-23
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM is the device name listed in this FDA 510(k) record. The listed applicant is Ep Dynamics, Inc.. It received FDA 510(k) clearance on 2012-08-23 under 510(k) number K111603. 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 LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM?

LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM is a medical device that received FDA 510(k) clearance on 2012-08-23. The listed applicant is Ep Dynamics, Inc.. The 510(k) number is K111603.

When did LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM receive FDA 510(k) clearance?

LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM received FDA 510(k) clearance on 2012-08-23, under 510(k) number K111603.

Who is the listed applicant for LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM?

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

What is the FDA product code for LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM?

The FDA product code for LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM is DYB.

Related Clinical Trials

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.

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Other records listing Ep Dynamics, Inc. as applicant

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.

K090867AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002

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

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

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