Medical Device Manufacturer · US , Fremont , CA

Cardima, Inc. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1993

Recent clearances: MODIFICATION TO: CARDIMA ABLATION SYSTEM, CARDIMA ABLATION SYSTEM, NAVIPORT DEFLECTABLE TIP GUIDING CATHETER

View 12 510(k) Devices ↓

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - Cardima, Inc. Cardiovascular ✕

12 devices

1-12 of 12

Cleared May 15, 2006

MODIFICATION TO: CARDIMA ABLATION SYSTEM

Cardiovascular · 59d

Cleared Jan 29, 2003

CARDIMA ABLATION SYSTEM

Cardiovascular · 224d

Cleared Jun 22, 1999

NAVIPORT DEFLECTABLE TIP GUIDING CATHETER

Cardiovascular · 553d

Cleared May 11, 1999

TRACER O-T-W MAPPING DEVICE

Cardiovascular · 652d

Cleared Oct 29, 1998

ELECTRODE SWITCHBOX, MODEL 11-081002

Cardiovascular · 78d

Cleared Jul 01, 1998

CARDIMA PATHFINDER 1.5F MAPPING MICROCATHETER

Cardiovascular · 398d

Cleared Jun 26, 1998

CARDIMA VUEPORT CORONARY SINUS BALLOON OCCLUSION GUIDING CATHETER

Cardiovascular · 297d

Cleared Nov 04, 1997

PATHFINDER 3MM MAPPING MICROCATHETER (01-082001)

Cardiovascular · 242d

Cleared Jan 29, 1997

Cardiovascular · 404d

Cleared Oct 05, 1995

CARDIMA, INC. FORERUNNER

Cardiovascular · 181d

Cleared Dec 21, 1993

CARDIMA TRACKER(R) INFUSION CATHETER

Cardiovascular · 195d

Cleared Sep 01, 1993

CARDIMA SEEKER AND STUBBIE GUIDEWIRES

Cardiovascular · 84d