# K961361: Asta-Cath

- Pathway: 510(k) (Traditional)
- Applicant: A+ Products
- Decided: Oct 31, 1996 after 205 days
- Product code: GBM (Catheter, Urethral)
- Device class: 2
- Regulation: 21 CFR 876.5130
- 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 K910876 (1991). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910876: Autocath (TM) Set, Cook Urological, Inc. (1991) Summary page 1.

## Most influential descendants
- K182511: SimplCath (2019), 0 descendants of its own

## Indications for use
The Asta-Cath™ female catheter guide is intended for use in the following situations: (1) As an assistive device for women who have difficulty performing intermittent self catheterization due to motor or visual disabilities; (n) As a teaching aide for women learning to catheterize themselves for the first time; (i) As a teaching aide for caregivers who will be catheterizing women; (iv) As an assistive device and teaching aide for women who are required to perform intermittent self catheterization temporanly following surgery.

Source page: https://510kreport.com/device/K961361
Methodology: https://510kreport.com/methodology