Atlas FDA

Bio-Medicus Adult Cannulae and Introducer

FDA 510(k) clearance K180453 · decided 2018-03-22

Clearance details

K-number
K180453
Device name
Bio-Medicus Adult Cannulae and Introducer
Applicant
Medtronic, Inc.
Decision
Substantially Equivalent
Date received
2018-02-20
Decision date
2018-03-22
Days to decision
30 days
Clearance type
Special
Product code
DWF
Device class
2
Regulation number
870.4210
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mounds View, MN, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

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Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310) (K250610)Sorin Group Italia S.R.L.2025-06-27
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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Aurora EV ICD (DVEA3E4) (P220012/S074)Medtronic, Inc.2026-07-31
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