# K964929: Peripherally Inserted Central Catheter

- Pathway: 510(k) (Traditional)
- Applicant: B.Braun Medical, Inc.
- Decided: Jun 2, 1997 after 175 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: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K861479 (1986). 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)
- K861479: Cavafix, Central Venous Catheter Kit, Burron Medical Products, Inc. (1986) Summary page 1.
- (no number) SoloPICC: named in the summary without a submission number

## Recalls of this device
- May 27, 2005 · Not classified · Z-1062-05: Reports that the tearaway introducer sheaths have cracked hubs/handles and/or improper peeling of the sheath during use.
- Nov 25, 2003 · Not classified · Z-0322-04: The CA 125 assay product inserts list the incorrect storage instructions for the CA 125 Calibrators and Controls, and the product information letter (PI-P) shipped with the products to correct the sto

## Indications for use
The indication for use is when the patient's condition requires the peripheral infusion of chemotherapy solutions and blood sampling.

Source page: https://510kreport.com/device/K964929
Methodology: https://510kreport.com/methodology