PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP
FDA 510(k) clearance K043272 · decided 2004-12-22
Clearance details
- K-number
- K043272
- Device name
- PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP
- Applicant
- Kendall
- Decision
- Substantially Equivalent
- Date received
- 2004-11-26
- Decision date
- 2004-12-22
- Days to decision
- 26 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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Recalls involving this device
No recalls on record reference this clearance.