# K001440: Nextstitch Cardiovascular Valve Suture

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Surgical Product (Genzyme Biosurgery)
- Decided: Nov 13, 2000 after 189 days
- Product code: GAT (Suture, Nonabsorbable, Synthetic, Polyethylene)
- Device class: 2
- Regulation: 21 CFR 878.5000
- 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.
23 later devices descend from it; 3 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K060165: Axyaflex Polyester Suture (2006), 11 descendants of its own
- K080684: WG-Surgical Sutures with Needle (2008), 9 descendants of its own
- K022410: Saph-Loop Ligating Loop (2002), 5 descendants of its own
- K161633: Rexlon, Rexsil (2017), 4 descendants of its own
- K153076: silky II POLYDEK, cottony II, TEVDEK II, NextStitch, DEKLENE II, DEKLENE MAXX Gabbay-Frater, NYLON, SILK, STAINLESS STEEL (2016), 4 descendants of its own

## Recalls of this device
- Jun 6, 2007 · Not classified · Z-1017-2007: Suture Diameter/Strength specification failure: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.

Source page: https://510kreport.com/device/K001440
Methodology: https://510kreport.com/methodology