# K130687: 2F & 3F Vascu-Sheath Tearaway Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Medical Components, Inc.
- Decided: Aug 15, 2013 after 155 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- 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: 3 generations back to K993191 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053092: Medcomp Vascu-Sheath II, Medcomp (2006) Summary page 1.

## Recalls of this device
- May 5, 2016 · Class II · Z-1924-2016: This recall has been initiated due to the product labeled with the incorrect expiration date.

## Indications for use
The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants, and children.

Source page: https://510kreport.com/device/K130687
Methodology: https://510kreport.com/methodology