# K150882: Edwards Suture Fastening System

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Jun 16, 2015 after 75 days
- Product code: HCF (Instrument, Ligature Passing And Knot Tying)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K933887 (1993). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141206: Edwards Lifesciences Thruport Knotting System, Edwards Lifesciences, LLC (2015) Summary page 4.

## Recalls of this device
- Mar 9, 2016 · Class II · Z-1575-2016: Panorama Central Station including the work station View Station, View Station and the eGateway will revert to the year 2000 when Daylight Savings Time (DST) occurs on March 13, 2016, or under various

## Indications for use
The Edwards Suture Fastening System is indicated for suture fastening in the approximation of soft tissue and prosthetic materials, including cardiovascular procedures with Edwards’ surgical heart valves and annuloplasty rings.

Source page: https://510kreport.com/device/K150882
Methodology: https://510kreport.com/methodology