# K091586: Vascu-Picc and Midline Catheters, Single, Double and Triple Lumen

- Pathway: 510(k) (Traditional)
- Applicant: Medcomp
- Decided: Jul 23, 2009 after 51 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K001901 (2000). 20 ancestors in all.
9 later devices descend from it; 5 cite it directly.
2 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003682: Medcomp Z-Cath, Medical Components, Inc. (2001) Summary page 1.
- K001901: Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model 3134135, C.R. Bard, Inc. (2000) Summary page 1.
- K043502: 6 FR Poly Per-Q-Cath Triple Lumen Picc, C.R. Bard, Inc. (2005) Summary page 1.
- K051991: Powerpicc, Poly Per-Q-Cath, 6 FR TL Poly Per-Q-Cath, Power Hohn and Power Line, C.R. Bard, Inc. (2005) Summary page 1.

## Most influential descendants
- K123292: T3 (2013), 2 descendants of its own
- K130034: Uni-Picc (2013), 2 descendants of its own
- K183219: Trio-CT Triple Lumen Catheter (2019), 1 descendant of its own
- K140270: Nexus Midline CT Catheter (2014), 1 descendant of its own
- K123617: 3F Pro-Picc (2013), 1 descendant of its own

## Indications for use
The Peripherally Inserted Central Vein Access catheters are designed for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. For central venous pressure monitoring (CVP), it is recommended that catheter lumen of 20 gauge or larger be used. The Midline catheters are indicated for short or long term peripheral access to the peripheral venous system for selected intravenous therapies and blood sampling. (See Contraindications). For blood therapy it is recommended that a 4French or larger catheter be used.

Source page: https://510kreport.com/device/K091586
Methodology: https://510kreport.com/methodology