# K001901: Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model 3134135

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Sep 19, 2000 after 89 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
250 later devices descend from it; 3 cite it directly.
16 of 251 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K012902: Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen Picc Catheter, Model 3246100 (2001), 247 descendants of its own
- K031129: Poly Per-Q-Cath Picc Catheters; Poly Radpicc (2003), 246 descendants of its own
- K034019: Poly Per-Q-Cath Picc Catheters (2004), 239 descendants of its own
- K033389: Powerpicc Catheters, Models 3175155, 3175135 (2004), 208 descendants of its own
- K050931: 6 FR DL Powerpicc Catheter (2005), 199 descendants of its own

## Recalls of this device
- May 21, 2026 · Class II · Z-2656-2026: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
- Aug 8, 2014 · Class II · Z-1271-2015: Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of 

Source page: https://510kreport.com/device/K001901
Methodology: https://510kreport.com/methodology