TOURNIQUET PRESSURE REGULATOR— 510(k) K871982

Name: FDA 510(k) clearance K871982
Creator: U.S. Food and Drug Administration
Published: 1987-06-09

Substantially Equivalent

Avec Scientific Design Corp.

FDA 510(k) clearance K871982 for TOURNIQUET PRESSURE REGULATOR, Substantially Equivalent on 1987-06-09. Applicant: Avec Scientific Design Corp.. Device class: 1.

Clearance details

Applicant: Avec Scientific Design Corp.
Product code: Code KCY
Device class: Class 1
Regulation: 21 CFR 878.5910
Advisory panel: General, Plastic Surgery
Date received: 1987-05-22
Decision date: 1987-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Philadelphia, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KCY

view all

K202919 — ATS 5000 Automatic Tourniquet Instrument2021-05-20
K162365 — T-Cuff2017-02-16
K123553 — ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM2013-08-09
K112874 — EZ VEIN INFLATABLE TOURNIQUET2011-10-17
K071140 — MRI COMPATIBLE THIGH TOURNIQUET, MODEL C0700022007-06-07

More clearances from Avec Scientific Design Corp.

view all

K883295 — CHOP SPINE FRAME1988-08-23
K874494 — KAMBIN LAMINECTOMY FRAME1987-11-23
K872544 — IRRIGATION PRESSURE MONITOR1987-09-04
K871981 — BILATERAL CONTINUOUS PASSIVE MOTION DEVICE1987-06-17
K871900 — OVER DRAPE LEG HOLDER1987-06-16

Adverse events under product code KCY

product code KCY

Malfunction: 868
Total: 868

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.