FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221
K Number: K030398
·
Decision May 23, 2003
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
24
Applicant Total
21
Review Days
106
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Basic Information
- Device Name
- CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221
- K Number
- K030398
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cardiacassist, Inc.
- Date Received
- February 6, 2003
- Decision Date
- May 23, 2003
- Product Code
- DQR
- 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 |
|---|---|---|---|
| DQR | Cannula, Catheter | FDA class 2 | Cardiovascular |
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| K162214 | Protek Solo 24 Fr Venous Cannula Set | Nov 30, 2016 | Substantially Equivalent |
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