SAFE-CONNECT VIAL DISPENSING SPIKE— 510(k) K970789

Name: FDA 510(k) clearance K970789
Creator: U.S. Food and Drug Administration
Published: 1997-05-01

Substantially Equivalent

Faulding Medical Device Co.

FDA 510(k) clearance K970789 for SAFE-CONNECT VIAL DISPENSING SPIKE, Substantially Equivalent on 1997-05-01. Applicant: Faulding Medical Device Co.. Device class: 2.

Clearance details

Applicant: Faulding Medical Device Co.
Product code: Code LHI
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1997-03-04
Decision date: 1997-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scottsdale, AZ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LHI

view all

K252987 — ADRx Admixture Device2026-06-12
K260301 — Vial Adapter2026-06-05
K250345 — Medline Bag Decanter2025-10-24
K251715 — FlowArt® Vial Access Device Vented2025-10-14
K251676 — Medline Microtek C-Flo Bag Decanter, Sterile (2000S) +3 more2025-09-16

More clearances from Faulding Medical Device Co.

view all

K962159 — STERILE AMBULATORY RESERVOIR 60ML/100ML1997-07-18
K970909 — SAFE-CONNECT I.V. SET1997-05-06
K971266 — SAFE-CONNECT Y-SITE ADAPTER CATALOG NO. 6815181997-05-01
K970524 — SAFE-CONNECT I.V. EXTENSION SET1997-04-22
K955775 — SAFECONNECT VALVE (CATALOG NO. XXXX)1996-11-15

Adverse events under product code LHI

product code LHI

Injury: 207
Malfunction: 7,820
Other: 3
Total: 8,030

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.