Cardima, Inc.
San Carlos, CA, US
Cardima, Inc. appears in FDA device records in San Carlos, CA. FDA records list 12 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 2 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 12 510(k) clearances for Cardima, Inc. between 1993 and 2006. The busiest year on record is 1998, with 3. The most recent is 2006, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 2 |
| 1995 | 1 |
| 1997 | 2 |
| 1998 | 3 |
| 1999 | 2 |
| 2003 | 1 |
| 2006 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K060715 | MODIFICATION TO: CARDIMA ABLATION SYSTEM | OCL | Substantially Equivalent | |
| K022008 | CARDIMA ABLATION SYSTEM | OCL | Substantially Equivalent | |
| K974683 | NAVIPORT DEFLECTABLE TIP GUIDING CATHETER | DQY | Substantially Equivalent | |
| K972803 | TRACER O-T-W MAPPING DEVICE | DRF | Substantially Equivalent | |
| K982835 | ELECTRODE SWITCHBOX, MODEL 11-081002 | DRF | Substantially Equivalent | |
| K971975 | CARDIMA PATHFINDER 1.5F MAPPING MICROCATHETER | DRF | Substantially Equivalent | |
| K973298 | CARDIMA VUEPORT CORONARY SINUS BALLOON OCCLUSION GUIDING CATHETER | DQY | Substantially Equivalent | |
| K970853 | PATHFINDER 3MM MAPPING MICROCATHETER (01-082001) | DRF | Substantially Equivalent | |
| K955802 | PATHFINDER | DRF | Substantially Equivalent | |
| K951603 | CARDIMA, INC. FORERUNNER | DQY | Substantially Equivalent | |
| K932800 | CARDIMA TRACKER(R) INFUSION CATHETER | KRA | Substantially Equivalent | |
| K932801 | CARDIMA SEEKER AND STUBBIE GUIDEWIRES | DQX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2581-2010 | Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208, manufactured by Cardima Inc, Fremont, CA | Sterility compromised-- The sterile pouch in which the product is packaged may be compromised, which could result in patient infection. | Terminated | ||
| Z-2580-2010 | Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208, manufactured by Cardima Inc, Fremont, CA | Sterility compromised-- The sterile pouch in which the product is packaged may be compromised, which could result in patient infection. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain