# K153297: Perifix and Contiplex Catheter

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Aug 12, 2016 after 273 days
- Product code: BSO (Catheter, Conduction, Anesthetic)
- Device class: 2
- Regulation: 21 CFR 868.5120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K896422 (1990). 15 ancestors in all.
No later device cites it as a predicate yet.
1 of 16 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042488: Perifix Catheter and Contiplex Catheter, B.Braun Medical, Inc. (2004) Summary page 4.

## Indications for use
The B. Braun Perifix catheters are regional anesthesia catheters intended to provide, via percutaneous administration, continuous and/or intermittent infusion of local anesthetics and analgesics near a nerve for regional anesthesia and pain management during the preoperative, perioperative and postoperative periods associated with general and orthopedic surgery as well as labor and delivery. Routes of administration are epidural. The catheters may remain indwelling for up to 72 hours. The B. Braun Contiplex catheters are regional anesthesia catheters intended to provide, via percutaneous administration, continuous and/or intermittent infusion of local anesthetics and analgesics near a nerve for regional anesthesia and pain management during the preoperative, perioperative and postoperative periods associated with general and orthopedic surgery. Routes of administration are perineural (peripheral nerve block). The catheters may remain indwelling for up to 72 hours.

Source page: https://510kreport.com/device/K153297
Methodology: https://510kreport.com/methodology