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

Cleared May 15, 2007

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

K070242 · OBJ

Cardiovascular · 95d

Cleared May 04, 2007

CARTO XP EP NAVIGATION SYSTEM, VERSION 9

K070240 · DQK

Cardiovascular · 99d

Cleared Aug 14, 2006

ESOPHAGEAL MAPPING CATHETER, MODEL D-1272-01-S

K061463 · DRF

Cardiovascular · 80d

Cleared Aug 14, 2006

REFSTAR EXTERNAL REFERENCE PATCH

K061468 · DRF

Cardiovascular · 80d

Cleared Jun 19, 2006

CARTO RMT EP NAVIGATION SYSTEM V8

K060047 · DRF

Cardiovascular · 164d

Cleared Mar 09, 2006

NOGA XP CARDIAC NAVIGATION SYSTEM WITH QWIKMAP SOFTWARE

K053194 · DQK

Cardiovascular · 114d

Cleared Sep 29, 2005

CARTO RMT EP NAVIGATION SYSTEM

K042681 · DQK

Cardiovascular · 365d

Cleared Sep 29, 2005

REFSTAR RMT EXTERNAL REFERENCE PATCH

K042998 · DRF

Cardiovascular · 332d

Cleared Sep 29, 2005

NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER

K052083 · DRF

Cardiovascular · 58d

Cleared Jun 24, 2005

CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & 7 FR

K050877 · DRF

Cardiovascular · 79d

Cleared Mar 30, 2005

FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM...

K050217 · MTD

Cardiovascular · 58d

Cleared Mar 21, 2005

CARTO XP EP NAVIGATION SYSTEM, SOFTWARE VERISON 8

K042999 · DQK

Cardiovascular · 140d

Cleared Jul 22, 2003

VARIABLE LASSO 2515 CIRCULAR MAPPING CATHETER

K031161 · DRF

Cardiovascular · 99d

Cleared Jan 09, 2003

CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM

K020863 · DQK

Cardiovascular · 297d

Cleared Nov 21, 2001

CARTO XP EP NAVIGATION SYSTEM

K013083 · DQK

Cardiovascular · 68d

Cleared Aug 31, 2000

BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220

K002333 · DRF

Cardiovascular · 30d

Cleared Jul 21, 2000

BIOSENSE WEBSTER PATIENT CABLE AND LEADWIRES

K001390 · DSA

Cardiovascular · 80d

Cleared May 10, 2000

PREFACE GUIDING SHEATH, MODELS 2-603M, 2-703M, 2-803M, 2-903M, 2-1003M, 2-1103M

K001139 · DYB

Cardiovascular · 30d

Cleared May 05, 2000

MODIFICATION TO CARTO EP NAVIGATION SYSTEM

K000190 · DQK

Cardiovascular · 113d

Cleared May 05, 2000

CARTO EP NAVIGATION SYSTEM

K000248 · DQK

Cardiovascular · 99d

Cleared May 04, 2000

NOGA CARDIAC NAVIGATION SYSTEM

K000332 · DQK

Cardiovascular · 91d

Cleared Dec 03, 1999

MODIFICATION TO CARTO EP NAVIGATION SYSTEM

K993729 · DQK

Cardiovascular · 29d

Cleared Sep 29, 1999

CARTO EP NAVIGATION SYSTEM

K992968 · DQK

Cardiovascular · 26d