# K130378: Respiguide Delivery System

- Pathway: 510(k) (Traditional)
- Applicant: Respicardia
- Decided: Oct 17, 2013 after 245 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
Longest line of descent: 3 generations back to K000659 (2000). 8 ancestors in all.
No later device cites it as a predicate yet.
1 of 9 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121051: Concierge Guiding Catheter, Merit Medical Systems, Inc. (2012) Summary page 1.
- K053171: Merit Impress Diagnostic Catheter, Merit Medical Systems, Inc. (2006) Summary page 1.
- K093004: Impress Angiographic Catheter with Hydrophilic Coating, Merit Medical Systems, Inc. (2010) Summary page 1.

## Indications for use
Respiguide outer guide catheter: The guide catheter is intended for use for intravascular introduction of interventional/diagnostic devices into peripheral vascular systems. Respiguide inner (angiographic) catheter: Angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedures.

Source page: https://510kreport.com/device/K130378
Methodology: https://510kreport.com/methodology