FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTERCOSTAL LOCKABLE-DIRECTABLE PORT
K Number: K011349
·
Decision Oct 5, 2001
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
50
Applicant Total
5
Review Days
156
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Basic Information
- Device Name
- INTERCOSTAL LOCKABLE-DIRECTABLE PORT
- K Number
- K011349
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1390
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medcanica, Inc.
- Date Received
- May 2, 2001
- Decision Date
- October 5, 2001
- Product Code
- DRC
- 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 |
|---|---|---|---|
| DRC | Trocar | FDA class 2 | Cardiovascular |
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