FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER
K Number: K934727
·
Decision Jan 10, 1994
Classifications
1
FEI Numbers
313
Registration Numbers
313
Same Product Code
70
Applicant Total
76
Review Days
101
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Basic Information
- Device Name
- REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER
- K Number
- K934727
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.4500
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cardiac Pacemakers, Inc.
- Date Received
- October 1, 1993
- Decision Date
- January 10, 1994
- Product Code
- DWS
- 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 |
|---|---|---|---|
| DWS | Instruments, Surgical, Cardiovascular | FDA class 1 | Cardiovascular |
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