# K060163: Cardioflon, Cardioxyl

- Pathway: 510(k) (Special)
- Applicant: Peters Surgical
- Decided: Oct 11, 2006 after 261 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K913101 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913101: Peters Cardioflon (TM) Suture, Promedica Products, Inc. (1992) Summary page 2.
- K930591: TI-Cron and Dacron Sutures, Davis & Geck, Inc. (1993) Summary page 2.

## Recalls of this device
- Jun 25, 2014 · Class II · Z-2676-2014: A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified.
- Jun 25, 2014 · Class II · Z-2675-2014: A potential splitting of the surface treatment of the thread ends on certain sutures has recently been identified.

## Indications for use
The CARDIOFLON® and CARDIOXYL sutures are intended for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, in ophthalmic surgery and in neurological surgery.

Source page: https://510kreport.com/device/K060163
Methodology: https://510kreport.com/methodology