# K981061: Intravascular Retrieval Device

- Pathway: 510(k) (Traditional)
- Applicant: Med Institute, Inc.
- Decided: May 26, 1998 after 64 days
- Product code: GCC (Dilator, Catheter)
- Device class: 1
- Regulation: 21 CFR 878.4200
- 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 K945586 (1997). 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)
- K945586: Flexible Dilating Sheath, Med Institute, Inc. (1997) Summary page 1.
- K970690: Locking Stylet 2, Cook Pacemaker Corp. (1997) Summary page 1.

## Indications for use
The Byrd Dilator Sheath Set is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects. The Byrd Stainless Steel Dilator Sheath is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects. The Byrd WORK STATION™ is intended for use in patients requiring the percutaneous retrieval of cardiac leads, indwelling catheters, fragments of catheter tubing or wire guides, and other foreign objects. The Byrd Telescoping Stainless Steel Dilator Sheath Set is intended for use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects. The NEEDLE’S EYE™ Snare 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/K981061
Methodology: https://510kreport.com/methodology