# K964447: Picc Catheter/Midline Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Menlo Care, Inc.
- Decided: Apr 16, 1997 after 161 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) L-Cath PICC and midline: named in the summary without a submission number
- (no number) One-Cath PICC and midline: named in the summary without a submission number
- (no number) Arrow PICC: named in the summary without a submission number
- (no number) SoloPICC and midline: named in the summary without a submission number
- (no number) Per-Q-Cath PICC: named in the summary without a submission number
- (no number) V-Cath PICC and midline: named in the summary without a submission number
- (no number) SiL-Cath PICC and midline catheters: named in the summary without a submission number

## Indications for use
Peripherally inserted central venous (PICC) and midline catheters placed for venous access or prolonged intravenous therapy.

Source page: https://510kreport.com/device/K964447
Methodology: https://510kreport.com/methodology