# K920755: L-Cath Peel Away System Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Luther Medical Products, Inc.
- Decided: Jun 7, 1993 after 474 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 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
- K091670: BD L-Cath Single and Dual Lument Catheters, Midline Catheter (2009), 1 descendant of its own
- K042461: Kendall Argyle 2 FR Double Lumen Neonatal/Pediatric Picc, Model 43304 (2004), 1 descendant of its own
- K230669: L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters (2023), 0 descendants of its own
- K132567: Argyle Peripherally Inserted Central Catheter Single Lumen, Argyle Peripherally Inserted Central Catheter Dual Lumen (2013), 0 descendants of its own

## Recalls of this device
- Mar 25, 2005 · Not classified · Z-0286-06: Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.
- Mar 25, 2005 · Not classified · Z-0283-06: Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.
- Mar 25, 2005 · Not classified · Z-0288-06: Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.
- Mar 25, 2005 · Not classified · Z-0282-06: Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.
- Mar 25, 2005 · Not classified · Z-0284-06: Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.
- Mar 25, 2005 · Not classified · Z-0285-06: Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.
- Mar 25, 2005 · Not classified · Z-0287-06: Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.
- Mar 9, 2004 · Not classified · Z-0785-04: Catheters have stylets extending past the catheter tip, which, if not noticed could cause injury upon insertion.
- Mar 9, 2004 · Not classified · Z-0783-04: Catheters have stylets extending past the catheter tip, which, if not noticed could cause injury upon insertion.
- Mar 9, 2004 · Not classified · Z-0784-04: Catheters have stylets extending past the catheter tip, which, if not noticed could cause injury upon insertion.

Source page: https://510kreport.com/device/K920755
Methodology: https://510kreport.com/methodology