Sapphire Sets— 510(k) K171346

Clearance details

Applicant

Icu Medical

Product code

Code MRZ

Device class

Class 2

Regulation

21 CFR 880.5725

Advisory panel

General Hospital

Date received

2017-05-08

Decision date

2017-08-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Lake Forest, IL, US

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• Z-0129-2020 — Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Microbore, 122 Inch. 1 unit per pouch; 50 pouches per caseClass II·Terminated·ICU Medical Inc·20190729
• Z-0130-2020 — Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set, Microbore, CLAVE Y-Site, 118 Inch. 1 unit per pouch; 50 pouches per caseClass II·Terminated·ICU Medical Inc·20190729
• Z-0131-2020 — Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch. 1 unit per pouch; 50 pouches per caseClass II·Terminated·ICU Medical Inc·20190729
• Z-0132-2020 — Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV 123 inch. 1 unit per pouch; 50 pouches per caseClass II·Terminated·ICU Medical Inc·20190729
• Z-0133-2020 — Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAVE Y-Site, 122 Inch. 1 unit per pouch; 50 pouches per caseClass II·Terminated·ICU Medical Inc·20190729
• Z-0134-2020 — Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch. 1 unit per pouch; 50 pouches per caseClass II·Terminated·ICU Medical Inc·20190729
• Z-0135-2020 — Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch. 1 unit per pouch; 50 pouches per caseClass II·Terminated·ICU Medical Inc·20190729
• Z-0147-2020 — Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch. 1 unit per pouch; 50 pouches per caseClass II·Terminated·ICU Medical Inc·20190729
• Z-0619-2019 — SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's epidural space. Sets are intended for use with Sapphire Infusion Systems.Class II·Terminated·ICU Medical Inc·20181108

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171346.