# K163353: Needle's Eye Snare Retrieval Set - 54cm

- Pathway: 510(k) (Special)
- Applicant: Cook Incorporated
- Decided: Jul 11, 2017 after 223 days
- Product code: DXE (Catheter, Embolectomy)
- Device class: 2
- Regulation: 21 CFR 870.5150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K961992 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961992: Needle's Eye Snare, Cook Pacemaker Corp. (1996) Summary page 4.

## Indications for use
The Needle’s Eye Snare® Retrieval Set – 54cm is intended for use in patients requiring the percutaneous retrieval of indwelling catheters, cardiac leads, fragments of catheter tubing or wire guides and other foreign objects.

Source page: https://510kreport.com/device/K163353
Methodology: https://510kreport.com/methodology