FIRST PICC INTRODUCER CATHETER— 510(k) K954906

Name: FDA 510(k) clearance K954906
Creator: U.S. Food and Drug Administration
Published: 1996-04-08

Substantially Equivalent

Becton Dickinson Vascular Access, Inc.

FDA 510(k) clearance K954906 for FIRST PICC INTRODUCER CATHETER, Substantially Equivalent on 1996-04-08. Applicant: Becton Dickinson Vascular Access, Inc.. Device class: 2.

Clearance details

Applicant: Becton Dickinson Vascular Access, Inc.
Product code: Code DYB
Device class: Class 2
Regulation: 21 CFR 870.1340
Advisory panel: Cardiovascular
Date received: 1995-10-25
Decision date: 1996-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sandy, UT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DYB

view all

K253526 — NAMIC Dilator and Sheath2026-07-29
K261529 — Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C) +2 more2026-07-06
K261242 — SimplGuide2026-06-25
K261950 — Health Line Tearaway Introducer2026-06-22
K261492 — FieldFlex Steerable Sheath2026-06-05

More clearances from Becton Dickinson Vascular Access, Inc.

view all

K971339 — INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS1997-12-24
K970259 — E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET1997-04-08
K964048 — FIRST MIDCATH CATHETER KIT1997-01-06
K964049 — FIRST MIDCATH CATHETER WITH DUAL LUMENS1997-01-06
K964050 — FIRST MIDCATH CATHETER1997-01-06

Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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.