# K943739: Softouch Diagnostic Intravascular Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Mallinckrodt Medical
- Decided: Nov 15, 1994 after 105 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
22 later devices descend from it; 5 cite it directly.
5 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K050168: Langston Dual Lumen Pressure Monitoring Catheter (2005), 15 descendants of its own
- K051395: Langston Dual Lumen Pressure Monitoring Catheter (2005), 8 descendants of its own
- K063723: Impella Recover LP 2.5 Percutaneous Cardiac Support System (2008), 7 descendants of its own
- K041909: Vascular Solutions Langston Dual Lumen Pigtail Catheter (DLP) (2004), 7 descendants of its own
- K061565: Langston Dual Lumen Catheter (2006), 6 descendants of its own

## Recalls of this device
- Sep 13, 2013 · Class II · Z-0045-2014: 4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape.
- May 2, 2013 · Class II · Z-1408-2013: Merit Medical Systems is recalling various lots of Performa Cardiac Multipacks containing a JR4.0 catheter due to a slight variation in tip shape.
- Nov 5, 2003 · Not classified · Z-0159-04: Angiographic catheter tips may separate during use.
- Nov 5, 2003 · Not classified · Z-0158-04: Angiographic catheter tips may separate during use.

Source page: https://510kreport.com/device/K943739
Methodology: https://510kreport.com/methodology