# K963965: CTS Midcab Stitcher

- Pathway: 510(k) (Traditional)
- Applicant: Cardiothoracic Systems, Inc.
- Decided: Mar 17, 1998 after 531 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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 its predicate without a number.
- (no number) Young Boomerang Needle Holder: named in the summary without a submission number
- (no number) Harris Boomerang Needle Holder: named in the summary without a submission number
- (no number) Millin Boomerang Needle Holder: named in the summary without a submission number
- (no number) U.S. Surgical EndoStitch Suturing Instrument: named in the summary without a submission number
- (no number) U.S. Surgical Endoscopic Needle Driver: named in the summary without a submission number

## Most influential descendants
- K994087: Superstitch (2000), 2 descendants of its own
- K012865: Superstitch Vascular Suturing Device (2001), 1 descendant of its own
- K020940: Superstitch Vascular Suturing Device, 6 French, Models 06-15-00X; Mid-Length 06-25-00X (2002), 0 descendants of its own

## Indications for use
The Vascular Stitcher is intended to be used in performing vascular suturing in general surgery, including endoscopic procedures.

Source page: https://510kreport.com/device/K963965
Methodology: https://510kreport.com/methodology