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Coaxial Dilator Set

by Boston Scientific

510(k) K974640

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK974640 Date13 Mar 1998ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-0759-04 FDA Unclassified (pre-2012) initiated 5 Mar 2004

    Kits containing 5 Fr dilators may be labeled as 4 Fr. Kits containing 4 Fr dilators may be labeled as 5 Fr.

Timeline

2 dated events

  1. Cleared FDA 510(k) K974640
  2. Recall initiated FDA recalls Z-0759-04

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
DRE
FDA applicant
Boston Scientific Corp
Device class
Class II
Regulation
21 CFR Part 870.1310
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Coaxial Dilator Set is a Dilator, Vessel, for Percutaneous Catheterization, designed to mechanically dilate vascular puncture sites. It consists of an inner tapered dilator and a slightly shorter outer dilator, enabling sequential dilation to facilitate the introduction of guidewires (0.035 or 0.038 inches) following percutaneous access via a 21-gauge needle.

Used in clinical settings, this single-use, sterile device is intended for over-the-wire procedures. The coaxial design allows for guidewire exchange and placement, with a proximal taper to ease introduction. Authorized under FDA 510(k) clearance (K974640), it adheres to Class II regulatory standards and is supplied as a complete, pre-sterilized set for immediate procedural use.

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