FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIMA ABLATION SYSTEM
K Number: K022008
·
Decision Jan 29, 2003
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
53
Applicant Total
12
Review Days
224
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Basic Information
- Device Name
- CARDIMA ABLATION SYSTEM
- K Number
- K022008
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cardima, Inc.
- Date Received
- June 19, 2002
- Decision Date
- January 29, 2003
- Product Code
- OCL
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OCL | Surgical Device, For Cutting, Coagulation, And/Or Ablation Of Tissue, Including Cardiac Tissue | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Cardima, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K060715 | MODIFICATION TO: CARDIMA ABLATION SYSTEM | May 15, 2006 | Substantially Equivalent |
| K974683 | NAVIPORT DEFLECTABLE TIP GUIDING CATHETER | Jun 22, 1999 | Substantially Equivalent |
| K972803 | TRACER O-T-W MAPPING DEVICE | May 11, 1999 | Substantially Equivalent |
| K982835 | ELECTRODE SWITCHBOX, MODEL 11-081002 | Oct 29, 1998 | Substantially Equivalent |
| K971975 | CARDIMA PATHFINDER 1.5F MAPPING MICROCATHETER | Jul 1, 1998 | Substantially Equivalent |
| K973298 | CARDIMA VUEPORT CORONARY SINUS BALLOON OCCLUSION GUIDING CATHETER | Jun 26, 1998 | Substantially Equivalent |
| K970853 | PATHFINDER 3MM MAPPING MICROCATHETER (01-082001) | Nov 4, 1997 | Substantially Equivalent |
| K955802 | PATHFINDER | Jan 29, 1997 | Substantially Equivalent |
| K951603 | CARDIMA, INC. FORERUNNER | Oct 5, 1995 | Substantially Equivalent |
| K932800 | CARDIMA TRACKER(R) INFUSION CATHETER | Dec 21, 1993 | Substantially Equivalent |