# K063048: Trans-Catheter Extractor

- Pathway: 510(k) (Traditional)
- Applicant: Tran Pa-C, Inc.
- Decided: Sep 14, 2007 after 345 days
- Product code: ODY (Tunneled Catheter Remover)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K122263: 14.5-16.0 French Cuffed Catheter Removal Device, Symmetry Surgical Singel Use (2012), 0 descendants of its own

## Recalls of this device
- Jun 11, 2024 · Class II · Z-2559-2024: Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to pat

## Indications for use
The Trans Catheter Extractor is a catheter accessory device intended for minimally invasive removal of tunneled long term catheters. The Trans Catheter Extractor is indicated for use with tunneled, double lumen Permcath catheters with cuff sizes ranging from 10.8 french to 14.5 french.

Source page: https://510kreport.com/device/K063048
Methodology: https://510kreport.com/methodology