Company ยท US
Cardima, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 2006. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 15, 2006 | K060715 | MODIFICATION TO: CARDIMA ABLATION SYSTEM Cardima, Inc. | OCL |
| Jan 29, 2003 | K022008 | CARDIMA ABLATION SYSTEM Cardima, Inc. | OCL |
| Jun 22, 1999 | K974683 | NAVIPORT DEFLECTABLE TIP GUIDING CATHETER Cardima, Inc. | DQY |
| May 11, 1999 | K972803 | TRACER O-T-W MAPPING DEVICE Cardima, Inc. | DRF |
| Oct 29, 1998 | K982835 | ELECTRODE SWITCHBOX, MODEL 11-081002 Cardima, Inc. | DRF |
| Jul 1, 1998 | K971975 | CARDIMA PATHFINDER 1.5F MAPPING MICROCATHETER Cardima, Inc. | DRF |
| Jun 26, 1998 | K973298 | CARDIMA VUEPORT CORONARY SINUS BALLOON OCCLUSION GUIDING CATHETER Cardima, Inc. | DQY |
| Nov 4, 1997 | K970853 | PATHFINDER 3MM MAPPING MICROCATHETER (01-082001) Cardima, Inc. | DRF |
| Jan 29, 1997 | K955802 | PATHFINDER Cardima, Inc. | DRF |
| Oct 5, 1995 | K951603 | CARDIMA, INC. FORERUNNER Cardima, Inc. | DQY |
| Dec 21, 1993 | K932800 | CARDIMA TRACKER(R) INFUSION CATHETER Cardima, Inc. | KRA |
| Sep 1, 1993 | K932801 | CARDIMA SEEKER AND STUBBIE GUIDEWIRES Cardima, Inc. | DQX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 27, 2010 | Cardima Inc Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208, manufactured by Cardima Inc, Fremont, CA Terminated |
OCL | K022008 K060715 |
| Sep 27, 2010 | Cardima Inc Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Model Number 01-242208, manufactured by Cardima Inc, Fremont, CA Terminated |
OCL | K022008 K060715 |