510(k) K063048
- Device
- TRANS-CATHETER EXTRACTOR
- Applicant
- TRAN PA-C, INC.
- 510(k) number
- K063048
- Product code
- ODY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-09-14
- Date received
- 2006-10-04
- Regulation
- 880.5970
- Classification name
- Tunneled Catheter Remover
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TOM TRAN
- Address
- 3348 Herringridge Dr. Orlando FL US 32812 32812
FDA Registration Numbers#
- 3006950086
- 3015225571
- 1721504
- 3012536737
- 3033589330
- 1061124
- 1125782
- 1123137
- 3015309643
Source Documents#
Other 510(k) Records For Product Code ODY #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K122263 | 14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE | Symmetry Medical | 2012-09-28 |
Legacy Summary#
summary
FDA Review#
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