FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LEAD STYLET
K Number: K905674
·
Decision Jan 30, 1991
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
27
Applicant Total
76
Review Days
43
Basic Information
- Device Name
- LEAD STYLET
- K Number
- K905674
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1380
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- CARDIAC PACEMAKERS, INC.
- Date Received
- December 18, 1990
- Decision Date
- January 30, 1991
- Product Code
- DRB
- 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 |
|---|---|---|---|
| DRB | Stylet, Catheter | FDA class 2 | Cardiovascular |
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