FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
CHANGES TO ENCOR PERVENOUS J-ATRIAL LEADS
K Number: K873772
·
Decision Oct 19, 1988
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
486
Applicant Total
4
Review Days
399
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Basic Information
- Device Name
- CHANGES TO ENCOR PERVENOUS J-ATRIAL LEADS
- K Number
- K873772
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Cordis Leads, Inc.
- Date Received
- September 16, 1987
- Decision Date
- October 19, 1988
- 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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