Sheath Introducer

by Bioteque Corp. United States 510(k)

510(k) K150932 Product code DRE

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK150932	Date22 Jul 2016Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number: K150932
FDA Product Code: DRE

Device Class: Class II
Regulation: 21 CFR Part 870.1310
Advisory Committee: Cardiovascular
FDA Decision: SESE Substantially Equivalent

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Properties & raw data

Show properties, registry sources and raw records

Sources (1)

FDA 510(k) K150932 24 fields · synced 22 Oct 2026