# K223178: SelectSite C304 Deflectable Catheter System, C315 Delivery System

- Pathway: 510(k) (Special)
- Applicant: Medtronic
- Decided: Nov 8, 2022 after 28 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SelectSite C304 Deflectable Catheter System: named in the summary without a submission number
- (no number) C315 Delivery Catheter: named in the summary without a submission number

## Indications for use
This non-therapeutic delivery system is intended to aid in the introduction and placement of cardiac leads into the right chambers of the heart. The leads are implanted in patients who are indicated for a cardiac implantable electronic device (CIED) for treatment of heart rhythm disorders. Refer to the respective CIED instructions for use for details about the types of heart rhythm abnormalities or patient conditions treated by each type of CIED. This non-therapeutic delivery system is intended to aid in the introduction and placement of cardiac leads in patients who are indicated for a cardiac implantable electronic device (CIED) for treatment of heart rhythm disorders. Refer to the respective CIED instructions for use for details about the types of heart rhythm abnormalities or patient conditions treated by each type of CIED.

Source page: https://510kreport.com/device/K223178
Methodology: https://510kreport.com/methodology