FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE
K Number: K123448
·
Decision Dec 13, 2012
Classifications
1
FEI Numbers
143
Registration Numbers
144
Same Product Code
136
Applicant Total
209
Review Days
35
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Basic Information
- Device Name
- AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE
- K Number
- K123448
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.4290
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic, Inc.
- Date Received
- November 8, 2012
- Decision Date
- December 13, 2012
- 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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