14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE)
FDA 510(k) clearance K062671 · decided 2006-11-03
Clearance details
- K-number
- K062671
- Device name
- 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING AND SILVER IMPREGNATED SLEEVE (PALINDROME SAPPHIRE)
- Applicant
- Kendall
- Decision
- Unknown
- Date received
- 2006-09-08
- Decision date
- 2006-11-03
- Days to decision
- 56 days
- Clearance type
- Special
- Product code
- MSD
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mansfield, MA, US
- Third-party review
- No
- Expedited review
- No
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