FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
COLIGN
K Number: K131124
·
Decision Aug 28, 2013
Classifications
1
FEI Numbers
143
Registration Numbers
144
Same Product Code
136
Applicant Total
2
Review Days
128
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Basic Information
- Device Name
- COLIGN
- K Number
- K131124
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4290
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jilin Coronado Medical , Ltd.
- Date Received
- April 22, 2013
- Decision Date
- August 28, 2013
- Product Code
- DTL
- 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 |
|---|---|---|---|
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by Jilin Coronado Medical , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K131411 | COSEAL | Sep 26, 2013 | Substantially Equivalent |