# K960883: Intraducer Peritoneal Catheter  6FRX3, 9FRX3 1/2, 10FRX4, 12FRX8

- Pathway: 510(k) (Traditional)
- Applicant: Taut, Inc.
- Decided: Mar 20, 1996 after 15 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Jan 19, 2007 · Not classified · Z-0428-2007: Taut, Inc. has become aware that some package seals are not intact, compromising the sterility of the catheters.

Source page: https://510kreport.com/device/K960883
Methodology: https://510kreport.com/methodology