FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER
K Number: K121006
·
Decision May 3, 2012
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
33
Applicant Total
105
Review Days
30
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Basic Information
- Device Name
- ENSITE ARRAY MULTI-ELECTRODE DIAGNOSTIC CATHETER
- K Number
- K121006
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1220
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- St Jude Medical
- Date Received
- April 3, 2012
- Decision Date
- May 3, 2012
- Product Code
- MTD
- Advisory Committee
- Cardiovascular
- 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 |
|---|---|---|---|
| MTD | Catheter, Intracardiac Mapping, High-Density Array | FDA class 2 | Cardiovascular |
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