ODY
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Tunneled Catheter Remover
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5970
- Medical specialty
- General Hospital
- FDA definition
- To assist in the removal of tunneled long term catheter cuffs using a minimal invasive technique by seperating the tissue ingrowth cuff from the surrounding tissue. Following seperation of the cuff from the tissue, the catheter can be safely removed from the body.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| 14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE (K122263) | Symmetry Medical | 2012-09-28 | + Add |
| TRANS-CATHETER EXTRACTOR (K063048) | Tran Pa-C, Inc. | 2007-09-14 | + Add |
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