THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM— 510(k) K884318

Clearance details

Applicant

Abbott Laboratories

Product code

Code KRB

Device class

Class 2

Regulation

21 CFR 870.1915

Advisory panel

Cardiovascular

Date received

1988-10-13

Decision date

1988-12-13

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Abbott Park, IL, US

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• Z-0661-2019 — Thermoset Room Temperature Closed Loop Injectate Delivery System. 1 unit per Cavity #3 Cavity Deep/20 pieces per case R1-6090Class II·Terminated·ICU Medical, Inc.·20181005
• Z-0662-2019 — Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #6x12x2.6 Cav/10 pieces per case R1-6090Class II·Terminated·ICU Medical, Inc.·20181005
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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K884318.