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Found 2 results

510(k) Data Aggregation

K Number

Device Name

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

Manufacturer

EP DYNAMICS, INC.

Date Cleared

2012-08-23

(442 days)

Product Code

DYB

Regulation Number

870.1340

Why did this record match?

Applicant Name (Manufacturer) :

EP DYNAMICS, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The EP Dynamics, Inc., LineBacker™ Transseptal Introducer is used to introduce various cardiovascular catheters into the left side of the heart through the interatrial septum.

Device Description

Not Found

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K Number

Device Name

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

Manufacturer

EP DYNAMICS, INC.

Date Cleared

2009-07-30

(121 days)

Product Code

DYB

Regulation Number

870.1340

Why did this record match?

Applicant Name (Manufacturer) :

EP DYNAMICS, INC.

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

The EP Dynamics, Inc. AirBloc™ Transseptal Introducer is used to introduce various cardiovascular catheters into the left side of the heart through the interatrial septum.

Device Description

Not Found

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