# K964331: Asc High Pressure Braided Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Adam Spencer Corp.
- Decided: Jan 13, 1997 after 75 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- 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 its predicate without a number.
- (no number) High Pressure Catheter Connector: named in the summary without a submission number

## Indications for use
ASC High Pressure Braided Tubes are accessory devices to angiographic catheters intended to provide an extended luminal connection between an angiographic injector and an angiographic catheter for the purpose of delivering radiopaque contrast medium to selected sites in the vascular system.

Source page: https://510kreport.com/device/K964331
Methodology: https://510kreport.com/methodology