FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
GlidePath 13F Long-Term Hemodialysis Catheter
K Number: K211410
·
Decision Jun 4, 2021
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
123
Applicant Total
34
Review Days
29
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Basic Information
- Device Name
- GlidePath 13F Long-Term Hemodialysis Catheter
- K Number
- K211410
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Bard Peripheral Vascular, Inc.
- Date Received
- May 6, 2021
- Decision Date
- June 4, 2021
- Product Code
- MSD
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| MSD | Catheter, Hemodialysis, Implanted | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MSD), ordered by most recent decision date.
Hemodialysis Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
End Cap
FDA 510(k)
FDA Class 2
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GlidePath Retro Long-Term Hemodialysis Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Pristine Long-Term Hemodialysis Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GlidePath 7.5F Long-Term Dialysis Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
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