Atlas FDA

SOF-SET MICRO QR INFUSION SET, MODELS 320 AND 321

FDA 510(k) clearance K991979 · decided 1999-09-03

Clearance details

K-number
K991979
Device name
SOF-SET MICRO QR INFUSION SET, MODELS 320 AND 321
Applicant
Medtronic Minimed
Decision
Substantially Equivalent
Date received
1999-06-14
Decision date
1999-09-03
Days to decision
81 days
Clearance type
Traditional
Product code
FPA
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Sylmar, 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

RecordFirmDate
Simplera System (P160007/S059)Medtronic Minimed2025-12-08
Simplera System (P160007/S057)Medtronic Minimed2025-12-05
Medtronic MiniMed 630G System (P150001/S110)Medtronic Minimed2025-10-16
Guardian Connect System Simplera System (P160007/S056)Medtronic Minimed2025-10-16
Guardian Connect System (P160007/S054)Medtronic Minimed2025-10-09
Simplera System (P160007/S055)Medtronic Minimed2025-09-12
Guardian Connect system (P160007/S053)Medtronic Minimed2025-08-25
Simplera (TM) System (P160007/S052)Medtronic Minimed2024-09-17