FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NUMED Z-MED PTV CATHERERS
K Number: K003643
·
Decision Dec 27, 2000
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
49
Review Days
30
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Basic Information
- Device Name
- NUMED Z-MED PTV CATHERERS
- K Number
- K003643
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- NuMED, Inc.
- Date Received
- November 27, 2000
- Decision Date
- December 27, 2000
- Product Code
- DQY
- 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
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| K190974 | D'Vill Introducer | May 14, 2019 | Substantially Equivalent |
| K171206 | D'Vill Introducer | Oct 20, 2017 | Substantially Equivalent |
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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 |