FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CentriMag Pre-connected Pack
K Number: K222297
·
Decision Dec 1, 2022
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
253
Applicant Total
12
Review Days
122
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Basic Information
- Device Name
- CentriMag Pre-connected Pack
- K Number
- K222297
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4350
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott
- Date Received
- August 1, 2022
- Decision Date
- December 1, 2022
- Product Code
- DTZ
- 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 |
|---|---|---|---|
| DTZ | Oxygenator, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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