510(k) K060509
- Device
- PALINDROME EMERALD 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH HEPARIN COATING
- Applicant
- TYCO HEALTHCARE GROUP
- 510(k) number
- K060509
- Product code
- NYU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-06-23
- Date received
- 2006-02-27
- Regulation
- 876.5540
- Classification name
- Catheter, Hemodialysis, Implanted, Coated
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KEITH MARTIN
- 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 |
|---|---|---|---|
| K112477 | PALINDROME H, SI, HSI CHRONIC CATHETER | Covidien | 2011-09-28 |
Legacy Summary#
summary
FDA Review#
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