# K961135: Input 10F/11/F Introducer Set (010101(10F), 011101(11F)

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Apr 30, 1996 after 40 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- 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 K940092 (1995). 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)
- K940092: Usci Input Introducer Set, Usci, Div. C.R. Bard, Inc. (1995) Summary page 1.
- (no number) Daig 11F Introducer: named in the summary without a submission number

## Indications for use
Input 10F/11F are indicated as percutaneous introducers that are used to facilitate placing a catheter through the skin into a vein or artery. Input 10F/11F are recommended for initial percutaneous introduction of a closed end catheter, temporary pacing electrode catheter or probe, or a balloon catheter. They may also be used as an instrument to exchange catheters during a procedure.

Source page: https://510kreport.com/device/K961135
Methodology: https://510kreport.com/methodology