# K971991: Gesco Per-Q-Cath Midline Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Bard Access Systems, Inc.
- Decided: Nov 7, 1997 after 182 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- 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) Per-Q-Cath® Midline Catheters: named in the summary without a submission number

## Indications for use
Per-Q-Cath® Midline Catheters are indicated for short or long term peripheral access to the peripheral venous system for selected intravenous therapies and blood sampling. A midline catheter is contraindicated for paticnts requiring solutions with final glucose concentrations above 10 percent and solutions with protein concentrations above 5 percent and paticnts requiring continuous infusion of vesicants.

Source page: https://510kreport.com/device/K971991
Methodology: https://510kreport.com/methodology