# K981368: Pasv Dual Lumen Peripherally Inserted Central Catheter (Picc) Model Number Pic-Numerous

- Pathway: 510(k) (Special)
- Applicant: Catheter Innovations, Inc.
- Decided: May 1, 1998 after 16 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
Longest line of descent: 1 generation back to K963097 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963097: Clampless Valved Catheter-Picc (CVC-Picc), Bmw Medical, Inc. (1996) Summary page 3.

## Indications for use
Catheter Innovations, Inc. PASV™ Dual Lumen Peripherally Inserted Central Catheter (PICC) is designed to establish peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy 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. Catheter Innovations, Inc. PASV™ Dual Lumen Peripherally Inserted Central Catheters (PICC) have the same intended use as our Single Lumen PICC Catheters (K963097).

Source page: https://510kreport.com/device/K981368
Methodology: https://510kreport.com/methodology