FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
ENDOCARDIAL BIPOLAR LEAD
K Number: K781456
·
Decision Dec 4, 1978
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
486
Applicant Total
3
Review Days
103
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Basic Information
- Device Name
- ENDOCARDIAL BIPOLAR LEAD
- K Number
- K781456
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- American Technology, Inc.
- Date Received
- August 23, 1978
- Decision Date
- December 4, 1978
- Product Code
- DTB
- 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 |
|---|---|---|---|
| DTB | Permanent Pacemaker Electrode | FDA class 3 | Cardiovascular |
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