# K960486: Ksea Model 383320 20 Angiomat

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz Endoscopy
- Decided: Oct 25, 1996 after 266 days
- Product code: DQI (Withdrawal/Infusion Pump)
- Device class: 2
- Regulation: 21 CFR 870.1800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The KSEA model 383320 20 Angiomat pump is designed to provide a clear field of view during percutaneous and intra-operative endoscopy of the peripheral vascular system. Please consult your angioscope manual for specific indications and contraindications for use.

Source page: https://510kreport.com/device/K960486
Methodology: https://510kreport.com/methodology