Atlas FDA

Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags

FDA 510(k) clearance K200630 · decided 2020-04-09

Clearance details

K-number
K200630
Device name
Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags
Applicant
Medtronic, Inc.
Decision
Substantially Equivalent
Date received
2020-03-10
Decision date
2020-04-09
Days to decision
30 days
Clearance type
Special
Product code
GWM
Device class
2
Regulation number
882.1620
Medical specialty
Neurology
Advisory committee
Neurology
Location
Irvine, CA, US
Third-party review
No
Expedited review
No

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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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