# K063363: Firmgrip Peripherally Inserted Catheter Device

- Pathway: 510(k) (Traditional)
- Applicant: Flexicath, Ltd.
- Decided: May 7, 2007 after 181 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: 3 generations back to K930473 (1994). 6 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 10 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 2.
- K992424: Seldiflex Long-Term Central Venous Catheter (40CM & 60CM in Length), Models 63244J20 & 63246J20, Plastimed Laboratoire Pharmaceutique (2000) Summary page 2.
- K920908: Over the Needle Splitable Catheter Assembly Type 1, Teleflexmedical, Inc. (1992) Summary page 2.

## Most influential descendants
- K080793: Firmgrip (2008), 2 descendants of its own
- K092629: SNM Firmgrip (2009), 1 descendant of its own
- K111939: M/29TM - Pressure Injectable (2012), 0 descendants of its own

## Indications for use
The FirmGripTM Peripherally Inserted Catheter Device is intended for use in patients requiring repeated access to the peripheral venous system for infusion or injection intravenous therapies and/or blood sampling.

Source page: https://510kreport.com/device/K063363
Methodology: https://510kreport.com/methodology