# K101885: Medtronic C315 Delivery Catheter

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Sep 9, 2010 after 65 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- 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: 9 generations back to K893658 (1989). 56 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080500: Modification to: Acumen Single-Lumen Delivery Sheath, Models BLS-10, BLS-9, BLS-7, Acumen Medical, Inc. (2008) Summary page 2.
- K090659: Attain Command 6250 Left Heart Delivery Systems and Guide Catheters for Left Heart Delivery, Medtronic, Inc. (2009) Summary page 2.

## Most influential descendants
- K190475: Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4 (2019), 5 descendants of its own
- K230363: CPS Locator 3D Delivery Catheter (2023), 3 descendants of its own
- K250828: CPS Locator 3D Plus Delivery Catheter (2025), 1 descendant of its own
- K192712: Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter (2020), 1 descendant of its own
- K261766: CPS Locator 3D Plus Delivery Catheter (2026), 0 descendants of its own

## Recalls of this device
- Sep 9, 2021 · Class II · Z-0173-2022: Medtronic is recalling three lots of unused C315HIS Delivery Catheters due to reports of an inability to pass a lead through the catheter.

## Indications for use
The C315 is indicated for the introduction of various types of pacing or defibrillator leads and catheters.

Source page: https://510kreport.com/device/K101885
Methodology: https://510kreport.com/methodology