VOLUME CONTROL DEVICE VCD-150— 510(k) K780465

Name: FDA 510(k) clearance K780465
Creator: U.S. Food and Drug Administration
Published: 1978-06-02

Substantially Equivalent

Sorensen Research

FDA 510(k) clearance K780465 for VOLUME CONTROL DEVICE VCD-150, Substantially Equivalent on 1978-06-02. Applicant: Sorensen Research. Device class: 1.

Clearance details

Applicant: Sorensen Research
Product code: Code KZD
Device class: Class 1
Regulation: 21 CFR 880.5420
Advisory panel: General Hospital
Date received: 1978-03-22
Decision date: 1978-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KZD

view all

K974074 — INFUSION DYNAMICS POWER INFUSER1998-02-17
K973843 — MSI PRESSURE INFUSOR1997-10-29
K953290 — OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP1995-10-07
K951988 — PRESSURIZER1995-06-14
K942933 — PRESSURE INFUSION CUFF1994-08-25

More clearances from Sorensen Research

view all

K833674 — ACCURATE MEASUREMENT DEVICE KG-AMD1984-01-25
K833673 — ACCURATE MEASUREMENT DEVICE EZ-AMD1983-12-29
K833094 — TRANSDUCER DOME SD1041983-11-03
K833095 — TRANSDUCER DOME SD1051983-11-03
K833096 — TRANSDUCER DOME DS1061983-11-03

Adverse events under product code KZD

product code KZD

Death: 4
Total: 4

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.