# K130896: Vascular Probe, Vascular Probe ES

- Pathway: 510(k) (Traditional)
- Applicant: Synovis Life Technologies, Inc.
- Decided: Apr 24, 2013 after 23 days
- Product code: DWP (Dilator, Vessel, Surgical)
- Device class: 2
- Regulation: 21 CFR 870.4475
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910682 (1991). 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)
- K910682: Robicsek Probe/Retractor, Bio-Vascular, Inc. (1991) Summary page 1.

## Recalls of this device
- Feb 22, 2024 · Class II · Z-1524-2024: The Surgical Tools and Cardiovascular Specialty marketing brochures distributed for Flo-Rester Disposable Internal Vessel Occluder, Flo-Thru Intraluminal Shunt, and Vascular Probe Intravascular Probe 
- Dec 6, 2023 · Class II · Z-0659-2024: Cardiovascular Surgery marketing brochure (US-AS46-220001) that was distributed for the products listed below contains inaccurate content that does not align with some of the products Instructions for

## Indications for use
The disposable Vascular Probe is intended to be used during coronary and peripheral vascular surgery to probe blood vessels distally and proximally for blockages, to measure the internal diameter of vessels, and to act as an intravascular retractor.

Source page: https://510kreport.com/device/K130896
Methodology: https://510kreport.com/methodology