DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS
FDA 510(k) clearance K102833 · decided 2011-11-18
Clearance details
- K-number
- K102833
- Device name
- DISPOSABLE HEMODIALYSIS ACCESS CATHETER SETS
- Applicant
- Foshan Nanhai Bai HE Medical Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2010-09-29
- Decision date
- 2011-11-18
- Days to decision
- 415 days
- Clearance type
- Traditional
- Product code
- MPB
- Device class
- 2
- Regulation number
- 876.5540
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Shanghai, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.