FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT
K Number: K033328
·
Decision Jan 16, 2004
Classifications
1
FEI Numbers
143
Registration Numbers
144
Same Product Code
136
Applicant Total
3
Review Days
92
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Basic Information
- Device Name
- NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT
- K Number
- K033328
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4290
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Novosci Corp.
- Date Received
- October 16, 2003
- Decision Date
- January 16, 2004
- 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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