# K981382: Pasv Dual Lumen Peripherally Inserted Midline Catheter Model Number Midline-Numerous

- Pathway: 510(k) (Special)
- Applicant: Catheter Innovations, Inc.
- Decided: May 1, 1998 after 15 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Catheter Innovations, Inc. PASV™ Dual Lumen Peripherally Inserted Midline Catheter is designed to establish peripheral access to the venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, analgesics, and blood products. It is also indicated for blood specimen withdrawal. This product is effective for venous access in adults, children and infants who require intravenous therapy. Warning: The PASV™ Dual Lumen Peripherally Inserted Midline Catheter is NOT indicated for infusion of the following: • Hypertonic nutrition solutions with final glucose concentrations greater than 10% • Continuously infused Vesicant Drugs • Any medication contraindicated for infusion into the peripheral system Catheter Innovations, Inc. PASV™ Dual Lumen Peripherally Inserted Midline Catheters have the same intended use as our Single Lumen Midline Catheters (K963215).

Source page: https://510kreport.com/device/K981382
Methodology: https://510kreport.com/methodology