Atlas FDA

MODIFICATION TO: CARDIMA ABLATION SYSTEM

FDA 510(k) clearance K060715 · decided 2006-05-15

Clearance details

K-number
K060715
Device name
MODIFICATION TO: CARDIMA ABLATION SYSTEM
Applicant
Cardima, Inc.
Decision
Substantially Equivalent
Date received
2006-03-17
Decision date
2006-05-15
Days to decision
59 days
Clearance type
Special
Product code
OCL
Device class
2
Regulation number
878.4400
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Fremont, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Mode recall (Z-2580-2010)Cardima Inc2010-09-27
Cardima Surgical Ablation Probe (SAP) Electrosurgical cutting and coagulation device, Mode recall (Z-2581-2010)Cardima Inc2010-09-27