FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
NUCLEUS-X PTV CATHETER
K Number: DEN080015
·
Decision Jun 11, 2012
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
21
Applicant Total
49
Review Days
1265
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Basic Information
- Device Name
- NUCLEUS-X PTV CATHETER
- K Number
- DEN080015
- Device Class
- FDA class 2
- Clearance Type
- Post-NSE
- Regulation Number
- 870.1255
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Applicant
- NuMED, Inc.
- Date Received
- December 24, 2008
- Decision Date
- June 11, 2012
- Product Code
- OZT
- 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 |
|---|---|---|---|
| OZT | Balloon Aortic Valvuloplasty | FDA class 2 | Cardiovascular |
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INOUE BALLOON A
FDA 510(k)
FDA Class 2
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| K160598 | REBOA Balloon Catheter | Jun 20, 2016 | Substantially Equivalent |
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| K131869 | PTS-X SIZING BALLOON CATHETER | Aug 8, 2013 | Substantially Equivalent |
| K122012 | Z-MED Z-MED II | Oct 4, 2012 | Substantially Equivalent |