# K042568: Excelsior 1018 and SL-10 Microcatheters

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Oct 15, 2004 after 24 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K960806 (1996). 4 ancestors in all.
25 later devices descend from it; 6 cite it directly.
0 of 30 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.
- K013789: Excelsior SL-10 Microcatheter, Models 168581, 168381, 168181, 168189, Boston Scientific, Target (2001) Summary page 1.

## Most influential descendants
- K113778: Excelsior XT-27 Microcatheter (2012), 8 descendants of its own
- K061963: Micrus Microcatheter Courier Pre-Shaped, Models MPS170045-00, MPS170090-00, MPS190045-00, MPS190090-00 (2006), 7 descendants of its own
- K070456: Micrus Courier Enzo Microcatheter 0.017 (2007), 6 descendants of its own
- K072526: Micrus Courier Enzo Microcatheter 0.0190 (2007), 5 descendants of its own
- K161921: SwiftNINJA Microcatheter (2016), 4 descendants of its own

## Recalls of this device
- Nov 4, 2013 · Class II · Z-0497-2014: 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.
- Nov 4, 2013 · Class II · Z-0494-2014: 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.
- Nov 4, 2013 · Class II · Z-0499-2014: 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.
- Nov 4, 2013 · Class II · Z-0495-2014: 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.
- Nov 4, 2013 · Class II · Z-0496-2014: 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.
- Nov 4, 2013 · Class II · Z-0500-2014: 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.
- Nov 4, 2013 · Class II · Z-0501-2014: 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.

## Indications for use
Boston Scientific's Excelsior' SL-10 Pre-Shaped Microcatheter and Excelsior' 1018' Pre-Shaped Microcatheter are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils to the peripheral, coronary, and neuro vasculature.

Source page: https://510kreport.com/device/K042568
Methodology: https://510kreport.com/methodology