# K974640: Coaxial Dilator Set

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Mar 13, 1998 after 88 days
- Product code: DRE (Dilator, Vessel, For Percutaneous Catheterization)
- Device class: 2
- Regulation: 21 CFR 870.1310
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
52 later devices descend from it; 2 cite it directly.
0 of 53 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) Coaxial dilator provided in Cook's Micropuncture Introducer Set: named in the summary without a submission number
- (no number) Boston Scientific's peelable sheath and dilator: named in the summary without a submission number

## Most influential descendants
- K990705: Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator Set (1999), 48 descendants of its own
- K071574: Stiffer Coaxial Micro-Introducer Kit (2007), 45 descendants of its own
- K090372: The Wand Microaccess Safety Introducer (2009), 32 descendants of its own
- K093022: The Picc Wand Peelable Safety Introducer (2010), 31 descendants of its own
- K081697: The Wand Microaccess Safety Introducer, Models 90001, 90002, 90005, 90006 (2008), 27 descendants of its own

## Recalls of this device
- Mar 5, 2004 · Not classified · Z-0759-04: Kits containing 5 Fr dilators may be labeled as 4 Fr. Kits containing 4 Fr dilators may be labeled as 5 Fr.

## Indications for use
The coaxial dilator set is used for percutaneous introduction of 0.035 inch or 0.038 inch guide wires into the vascular system following a 21 Ga. needle stick.

Source page: https://510kreport.com/device/K974640
Methodology: https://510kreport.com/methodology