Atlas FDA

3M Attest Super Rapid 5 Steam-Plus Challenge Pack

FDA 510(k) clearance K193154 · decided 2020-02-07

Clearance details

K-number
K193154
Device name
3M Attest Super Rapid 5 Steam-Plus Challenge Pack
Applicant
3M Company
Decision
Substantially Equivalent
Date received
2019-11-14
Decision date
2020-02-07
Days to decision
85 days
Clearance type
Traditional
Product code
FRC
Device class
2
Regulation number
880.2800
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
St. Paul, MS, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed to qualify a recall (Z-2639-2023)3M Company - Health Care Business2023-09-26
3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designed to qualify recall (Z-2640-2023)3M Company - Health Care Business2023-09-26

PMA approvals by this applicant

RecordFirmDate
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S011)3M Company1994-11-28
CENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S010)3M Company1994-05-19
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S006)3M Company1992-12-31
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S009)3M Company1992-03-13
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S008)3M Company1992-01-28
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S007)3M Company1990-10-17
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S005)3M Company1990-03-08
KENNEDY LAD(TM) LIGAMENT AUGMENTATION DEVICE (P850069/S004)3M Company1989-11-22