SHILEY ARTERIAL FILTER— 510(k) K811379

Substantially Equivalent

Shiley, Inc.

FDA 510(k) clearance K811379 for SHILEY ARTERIAL FILTER, Substantially Equivalent on 1981-06-09. Applicant: Shiley, Inc.. Device class: 2.

Clearance details

Applicant: Shiley, Inc.
Product code: Code DTM
Device class: Class 2
Regulation: 21 CFR 870.4260
Advisory panel: Cardiovascular
Date received: 1981-05-15
Decision date: 1981-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Shiley, Inc.

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K911876 — SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR12001991-08-09
K910923 — BCD ADVANCED1991-04-09
K901548 — BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS1991-01-14

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