Biosense Webster, Inc. - FDA 510(k) Cleared Devices

Cleared Jul 01, 2014

CARTO 3 EP NAVIGATION SYSTEM, VERSION 4.2

K133916 · DQK

Cardiovascular · 190d

Cleared Jan 24, 2014

CARTO3 EP NAVIGATION SYSTEM, VERSION 3.2

K132782 · DQK

Cardiovascular · 140d

Cleared Aug 14, 2013

LASSO NAV DUO LOOP CATHETER

K130602 · DRF

Cardiovascular · 160d

Cleared Mar 05, 2013

PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER

K123837 · MTD

Cardiovascular · 82d

Cleared May 24, 2012

PENTARAY NAV HIGH-DENSITY MAPPING CATHETER

K120425 · MTD

Cardiovascular · 101d

Cleared May 07, 2012

CARTO(R) EP NAVIGATION SYSTEM, VERSION 3.0 (WITH STANDARD LOCATION PAD)

K120550 · DQK

Cardiovascular · 74d

Cleared Dec 05, 2011

LASSO 2515 NAV ECO VARIABLE CATHETER LASSO NAV ECO CATHETER CONTINUED FROM...

K113213 · DRF

Cardiovascular · 34d

Cleared Nov 18, 2011

SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER

K112050 · OBJ

Cardiovascular · 123d

Cleared Oct 05, 2011

CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2

K112007 · DQK

Cardiovascular · 83d

Cleared May 02, 2011

WEBSTER DUO-DECAPOLAR CATHETER

K101991 · DRF

Cardiovascular · 292d

Cleared Jan 21, 2011

CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.0 (W/STANDARD LOCATION PAD),CARTO3...

K103746 · DQK

Cardiovascular · 29d

Cleared Jun 22, 2010

SOUNDSTAR 3D ULTRASOUND CATHETER MODEL M-5723-12

K101138 · OBJ

Cardiovascular · 61d

Cleared Jun 22, 2010

WEBSTER CS CATHETER WITH EZ STEER TECHNOLOGY, WEBSTER CS CATHETER WITH EZ...

K101345 · DRF

Cardiovascular · 40d

Cleared Jun 18, 2010

LASSO NAV CATHETER

K093376 · DRF

Cardiovascular · 232d

Cleared Jun 18, 2010

CARTO XP EP NAVIGATION SYSTEM, VERSION 10

K093566 · DQK

Cardiovascular · 212d

Cleared Dec 04, 2009

SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05

K091352 · OBJ

Cardiovascular · 211d

Cleared Dec 04, 2009

CARTO 3 VERSION 1.05 EP NAVIGATION SYSTEM AND ACCESSORIES

K093455 · DQK

Cardiovascular · 29d

Cleared Oct 13, 2009

CARTO 3 EP NAVIGATION SYSTEM, V1.0 AND ACCESSORIES

K090017 · DQK

Cardiovascular · 284d

Cleared Oct 01, 2009

CARTO RMT EP NAVIGATION SYSTEM V8

K091789 · DQK

Cardiovascular · 106d

Cleared Sep 04, 2009

CORONARY SINUS DEFLECTABLE MAPPING CATHETER, MODEL D-1263-01, WEBSTER CS...

K090898 · DRF

Cardiovascular · 156d

Cleared Aug 07, 2009

SOUNDSTAR 3D ULTRASOUND CATHETER, MODEL M-5723-12

K092064 · OBJ

Cardiovascular · 30d

Cleared Mar 24, 2009

REFSTAR PLUS WITH QWIKPATCH EXTERNAL REFERENCE PATCH, MODEL D-1210-03,...

K090120 · DRF

Cardiovascular · 62d

Cleared Jan 06, 2009

VARIABLE LASSO NAV CATHETER, MODELS: D-1290-01, D-1290-02

K081258 · DRF

Cardiovascular · 249d

Cleared Apr 23, 2008

CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02

K080425 · DRF

Cardiovascular · 68d

Cleared Nov 19, 2007

CARTO 3 NAVIGATION SYSTEM (MODEL:FG-5400-00), CARTO 3 EXTERNAL REFERENCE...

K072202 · DQK

Cardiovascular · 103d