FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set
K Number: K162181
·
Decision Jan 6, 2017
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
102
Applicant Total
5
Review Days
155
Basic Information
- Device Name
- Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set
- K Number
- K162181
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CARDIACASSIST INC.
- Date Received
- August 4, 2016
- Decision Date
- January 6, 2017
- Product Code
- DRE
- 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 |
|---|---|---|---|
| DRE | Dilator, Vessel, For Percutaneous Catheterization | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| K110493 | TANDEMHEART PUMP | Sep 20, 2011 | Substantially Equivalent |