# K963097: Clampless Valved Catheter-Picc (CVC-Picc)

- Pathway: 510(k) (Traditional)
- Applicant: Bmw Medical, Inc.
- Decided: Oct 18, 1996 after 70 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: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Groshong Long-term PICC: named in the summary without a submission number
- (no number) HDC V-Cath® PICC: named in the summary without a submission number

## Most influential descendants
- K981368: Pasv Dual Lumen Peripherally Inserted Central Catheter (Picc) Model Number Pic-Numerous (1998), 0 descendants of its own

## Recalls of this device
- Mar 5, 2004 · Not classified · Z-1051-05: Lumens may have incorrect lumen size marked on them.
- Mar 5, 2004 · Not classified · Z-1049-05: Lumens may have incorrect lumen size marked on them.
- Mar 5, 2004 · Not classified · Z-1050-05: Lumens may have incorrect lumen size marked on them.
- Mar 5, 2004 · Not classified · Z-1052-05: Lumens may have incorrect lumen size marked on them.

## Indications for use
BMW’s CVC-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.

Source page: https://510kreport.com/device/K963097
Methodology: https://510kreport.com/methodology