FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
ACUTE AND CHRONIC CATHETER REPAIR KIT
K Number: K092797
·
Decision Nov 19, 2009
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
10
Applicant Total
12
Review Days
69
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Basic Information
- Device Name
- ACUTE AND CHRONIC CATHETER REPAIR KIT
- K Number
- K092797
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Kendall
- Date Received
- September 11, 2009
- Decision Date
- November 19, 2009
- Product Code
- NFK
- 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 |
|---|---|---|---|
| NFK | Kit, Repair, Catheter, Hemodialysis | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NFK), ordered by most recent decision date.
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
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CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
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REPAIR KIT FOR XPRESSO, DECATHLON, AND ALTA LR CATHETERS
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CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
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FDA Class 2
·Gastroenterology, Urology
RETRO REPAIR KIT, MODEL PRRK5
FDA 510(k)
FDA Class 2
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MEDCOMP REPAIR KIT, MODEL ASPCRPK
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Kendall
| K Number | Device Name | ||
|---|---|---|---|
| K062671 | 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE) | Nov 3, 2006 | Unknown |
| K060972 | KEDALL 14.5 FR CHRONIC HEMODIALYSIS CATHETER W/SILVER IMPREGNATED SLEEVE (PALINDROME RUBY) | Aug 4, 2006 | Substantially Equivalent |
| K053410 | GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR | Jan 6, 2006 | Substantially Equivalent |
| K051584 | 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY | Oct 6, 2005 | Substantially Equivalent |
| K043272 | PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP | Dec 22, 2004 | Substantially Equivalent |
| K042461 | KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304 | Dec 10, 2004 | Substantially Equivalent |
| K042572 | KENDALL CO2NFIRM NOW CO2 DETECTOR | Nov 5, 2004 | Substantially Equivalent |
| K041914 | PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER | Sep 27, 2004 | Substantially Equivalent |
| K041006 | TANDEM-CATH HEMODIALYSIS CATHETER, MODEL 10 FR | May 19, 2004 | Substantially Equivalent |
| K040388 | NEXT GENERATION SALEM SUMP | May 17, 2004 | Substantially Equivalent |