T.E.D. SEQUENTIAL COMPRESSION SLEEVES— 510(k) K781357

Name: FDA 510(k) clearance K781357
Creator: U.S. Food and Drug Administration
Published: 1978-09-20

Substantially Equivalent

Kendall Research Center

FDA 510(k) clearance K781357 for T.E.D. SEQUENTIAL COMPRESSION SLEEVES, Substantially Equivalent on 1978-09-20. Applicant: Kendall Research Center. Device class: 2.

Clearance details

Applicant: Kendall Research Center
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 1978-08-08
Decision date: 1978-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K780062 — CATHETER/HEMOSTATIC/GERIATRIC1978-02-14
K780120 — ANESTHESIA TRAY, CAUDAL1978-02-06
K772133 — URINE SPECIMEN COLLECTING DEVICE1977-11-28

Recalls naming K781357

K-number listed on FDA's recall record

Z-1041-2019 — Kendall SCD Express Sterile Sleeves (Thigh Length), Model Number 9736Class II·Terminated·COVIDIEN LLC·20190215

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K781357.

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