510(k) K112477
- Device
- PALINDROME H, SI, HSI CHRONIC CATHETER
- Applicant
- COVIDIEN
- 510(k) number
- K112477
- Product code
- NYU
- Decision
- Substantially Equivalent - Kit (SESK)
- Decision date
- 2011-09-28
- Date received
- 2011-08-29
- Regulation
- 876.5540
- Classification name
- Catheter, Hemodialysis, Implanted, Coated
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- WING NG
- Address
- 15 Hampshire St. Mansfield MA US 02048 02048
FDA Registration Numbers#
- 3009211636
- 3014461810
- 3015453963
- 9610849
- 1319639
- 1282497
- 3030574705
- 3017210488
Source Documents#
Other 510(k) Records For Product Code NYU #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K060509 | PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING | Tyco Healthcare Group | 2006-06-23 |
Legacy Summary#
summary
FDA Review#
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