FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Attachable Cath Lab Hemostasis Valve
K Number: K152528
·
Decision Dec 2, 2015
Classifications
1
FEI Numbers
143
Registration Numbers
144
Same Product Code
136
Applicant Total
14
Review Days
90
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Basic Information
- Device Name
- Attachable Cath Lab Hemostasis Valve
- K Number
- K152528
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4290
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Galt Medical Corp.
- Date Received
- September 3, 2015
- Decision Date
- December 2, 2015
- 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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