FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR
K Number: K024156
·
Decision Jan 14, 2003
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
102
Applicant Total
49
Review Days
28
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Basic Information
- Device Name
- PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR
- K Number
- K024156
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.3620
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Oscor, Inc.
- Date Received
- December 17, 2002
- Decision Date
- January 14, 2003
- Product Code
- DTD
- 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 |
|---|---|---|---|
| DTD | Pacemaker Lead Adaptor | FDA class 2 | Cardiovascular |
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