DESERET POSITIONAL SUTURE WING— 510(k) K915495

Name: FDA 510(k) clearance K915495
Creator: U.S. Food and Drug Administration
Published: 1992-04-06

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K915495 for DESERET POSITIONAL SUTURE WING, Substantially Equivalent on 1992-04-06. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 1.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code KMK
Device class: Class 1
Regulation: 21 CFR 880.5210
Advisory panel: General Hospital
Date received: 1991-12-09
Decision date: 1992-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sandy, UT, US

Download summary PDF View on FDA.gov ↗

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K963365 — MULTI-PURPOSE MEDICAL TUBE HOLDER1996-10-11
K941098 — SECURE-SITE1995-08-09
K943147 — STATLOCK CV1994-09-29

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Adverse events under product code KMK

product code KMK

Malfunction: 461
Other: 1
Total: 462

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.