FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INSTRUMENT DAMPING PORT
K Number: K011373
·
Decision Oct 12, 2001
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
50
Applicant Total
5
Review Days
161
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Basic Information
- Device Name
- INSTRUMENT DAMPING PORT
- K Number
- K011373
- 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 4, 2001
- Decision Date
- October 12, 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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Other Clearances by Medcanica, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K011349 | INTERCOSTAL LOCKABLE-DIRECTABLE PORT | Oct 5, 2001 | Substantially Equivalent |
| K994232 | PHALANGEAL FIXATION SYSTEM | Mar 1, 2000 | Substantially Equivalent |
| K991486 | ULTRA-CBX | Nov 5, 1999 | Substantially Equivalent |
| K991064 | METACARPAL FIXATION SYSTEM | Jun 23, 1999 | Substantially Equivalent |