# K974617: Peripheral Vascular Dilator

- Pathway: 510(k) (Traditional)
- Applicant: Endovascular Instruments, Inc.
- Decided: Dec 1, 1998 after 355 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices 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) Cook, Inc.’s Dotter Transluminal Dilator: named in the summary without a submission number
- (no number) Pilling Weck’s Amato Dilators: named in the summary without a submission number

## Most influential descendants
- K012256: Gelbish Vascular Dilator (2001), 2 descendants of its own
- K030260: Gelbfish Flex Vascular Dilator (2003), 0 descendants of its own
- K023507: Modification to Gelbfish Vascular Dilators (2002), 0 descendants of its own

## Indications for use
The EndoVascular Instrument Peripheral Vascular Dilator is intended to be used to enlarge or calibrate a vessel as an adjunctive procedure to other interventional procedures such as catheterization.

Source page: https://510kreport.com/device/K974617
Methodology: https://510kreport.com/methodology