Medtronic Extended Infusion Set

Set, Administration, Intravascular

Unomedical A/S

The following data is part of a premarket notification filed by Unomedical A/s with the FDA for Medtronic Extended Infusion Set.

Pre-market Notification Details

• Device ID: K210544
• 510k Number: K210544
• Device Name: Medtronic Extended Infusion Set
• Classification: Set, Administration, Intravascular
• Applicant: Unomedical A/S Aaholmvej 1-3 Osted, DK 4320
• Contact: Lone Sylvest Vestergaard Jepsen
• Correspondent: Lone Sylvest Vestergaard Jepsen; Unomedical A/S Aaholmvej 1-3 Osted, DK 4320
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-02-24
• Decision Date: 2021-07-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05705244023352	K210544	000
05705244025486	K210544	000
05705244025516	K210544	000
05705244025547	K210544	000
05705244023543	K210544	000
05705244023598	K210544	000
05705244022669	K210544	000
05705244022690	K210544	000
05705244022720	K210544	000
05705244025455	K210544	000
05705244025424	K210544	000
05705244023413	K210544	000
05705244023444	K210544	000
05705244023475	K210544	000
05705244023505	K210544	000
05705244023567	K210544	000
05705244025332	K210544	000
05705244025363	K210544	000
05705244025394	K210544	000
05705244022751	K210544	000
05705244022782	K210544	000
05705244023116	K210544	000
05705244023147	K210544	000
05705244023178	K210544	000
05705244023208	K210544	000
05705244023239	K210544	000
05705244023260	K210544	000
05705244023291	K210544	000
05705244023321	K210544	000
05705244023086	K210544	000
05705244023055	K210544	000
05705244022812	K210544	000
05705244022843	K210544	000
05705244022874	K210544	000
05705244022904	K210544	000
05705244022935	K210544	000
05705244022966	K210544	000
05705244022997	K210544	000
05705244023024	K210544	000
05705244023383	K210544	000