# K013789: Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific, Target
- Decided: Dec 6, 2001 after 22 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- 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: 2 generations back to K960806 (1996). 3 ancestors in all.
81 later devices descend from it; 4 cite it directly.
0 of 85 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994155: Excelsior 1018 Microcatheter, Boston Scientific, Target (2000) Summary page 1.
- K925813: Diagnostic Intravascular Catheter, Target Therapeutics (1994) Summary page 1.

## Most influential descendants
- K083343: Headway 17 Microcatheter (2008), 39 descendants of its own
- K042568: Excelsior 1018 and SL-10 Microcatheters (2004), 25 descendants of its own
- K032494: PVS 1700 Steerable Delivery System Microcatheter (2003), 20 descendants of its own
- K093160: Headway 21 Microcatheter, Model: MC212150S (2009), 19 descendants of its own
- K041123: Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703 (2004), 17 descendants of its own

## Recalls of this device
- Nov 4, 2013 · Class II · Z-0498-2014: Products were shipped labeled with "use by" dates that exceed currently available shelf-life data. All products remain within the earliest expiration date of April 2015.
- Oct 7, 2008 · Not classified · Z-0627-2009: Packaging issue may result in failure to maintain sterile barrier.

## Indications for use
The Excelsior SL-10 Microcatheter is intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary and neurovasculature.

Source page: https://510kreport.com/device/K013789
Methodology: https://510kreport.com/methodology