FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NUMED Z-5 ATRIOSEPTOSTOMY CATHETER
K Number: K001804
·
Decision Jul 12, 2000
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
19
Applicant Total
49
Review Days
27
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Basic Information
- Device Name
- NUMED Z-5 ATRIOSEPTOSTOMY CATHETER
- K Number
- K001804
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.5175
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- NuMED, Inc.
- Date Received
- June 15, 2000
- Decision Date
- July 12, 2000
- Product Code
- DXF
- 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 |
|---|---|---|---|
| DXF | Catheter, Septostomy | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| K211134 | BIB Stent Placement Catheter | May 27, 2021 | Substantially Equivalent |
| K190974 | D'Vill Introducer | May 14, 2019 | Substantially Equivalent |
| K171206 | D'Vill Introducer | Oct 20, 2017 | Substantially Equivalent |
| K161451 | BIB Stent Placement Catheter | Sep 22, 2016 | Substantially Equivalent |
| K160598 | REBOA Balloon Catheter | Jun 20, 2016 | Substantially Equivalent |
| K160889 | BIB Stent Placement Catheter | May 20, 2016 | Substantially Equivalent |
| K131869 | PTS-X SIZING BALLOON CATHETER | Aug 8, 2013 | Substantially Equivalent |
| K122012 | Z-MED Z-MED II | Oct 4, 2012 | Substantially Equivalent |