# K213203: Provena (TM) Midline Catheter

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: May 13, 2022 after 226 days
- Product code: PND (Midline Catheter)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K001901 (2000). 29 ancestors in all.
No later device cites it as a predicate yet.
2 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162900: PowerMidline Catheter, C.R. Bard, Inc. (2016) Summary page 4.

## Recalls of this device
- May 21, 2026 · Class II · Z-2667-2026: Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

## Indications for use
The Provena™ Midline Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The Provena™ Midline Catheters are suitable for use with power injectors.

Source page: https://510kreport.com/device/K213203
Methodology: https://510kreport.com/methodology