FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM)
K Number: K010399
·
Decision Aug 14, 2001
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
123
Applicant Total
15
Review Days
186
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Basic Information
- Device Name
- DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM)
- K Number
- K010399
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Diatek, Inc.
- Date Received
- February 9, 2001
- Decision Date
- August 14, 2001
- 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 |
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|---|---|---|---|
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| K841827 | ENTEROPORT NUTRITION PUMP | Jul 27, 1984 | Substantially Equivalent |
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| K833568 | DIATEK 600 THERMOMETER SYSTEM | Jan 10, 1984 | Substantially Equivalent |
| K830565 | SECURA SET SECONDARY ADMIN. SET | Mar 9, 1983 | Substantially Equivalent |
| K830377 | SECURA SET PRIMARY ADMIN. SET | Mar 1, 1983 | Substantially Equivalent |
| K830355 | SECURA IV VOLUMETRIC INFUSION PUMP | Mar 1, 1983 | Substantially Equivalent |