# K971607: Medi-Tech 4 and 5 French Nighthawk Flush Angiographic Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Jul 24, 1997 after 84 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) Medi-tech® 4 and 5 F Imager™ Tennis Racket™ Flush catheters: named in the summary without a submission number

## Indications for use
The Medi-tech® 4 and 5 French Nighthawk™ Flush Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.

Source page: https://510kreport.com/device/K971607
Methodology: https://510kreport.com/methodology