Atlas FDA

3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing

FDA 510(k) clearance K153410 · decided 2017-05-15

Clearance details

K-number
K153410
Device name
3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing
Applicant
3M Company
Decision
Substantially Equivalent
Date received
2015-11-25
Decision date
2017-05-15
Days to decision
537 days
Clearance type
Traditional
Product code
SEL
Device class
U
Medical specialty
Unknown
Advisory committee
Unknown
Location
St. Paul, 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.

RecordFirmDate
3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing (K171908)3M Company2017-07-11
BIOPATCH ANTIMICROBIAL DRESSING (K003229)Integra Lifesciences Corp.2001-10-26

Recalls involving this device

RecordFirmDate
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R recall (Z-0038-2025)3M Company - Health Care Business2024-10-09

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