Atlas FDA

FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution

FDA 510(k) clearance K152129 · decided 2015-10-29

Clearance details

K-number
K152129
Device name
FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution
Applicant
Baxter Healthcare Corporation
Decision
Substantially Equivalent
Date received
2015-07-31
Decision date
2015-10-29
Days to decision
90 days
Clearance type
Traditional
Product code
KDJ
Device class
2
Regulation number
876.5630
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Round Lake, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Baxter MiniCap Disconnect Cap with Povidone-Iodine Solution, 5C4466P; Accessory to disposa recall (Z-1213-2023)Baxter Healthcare Corporation2023-03-03

PMA approvals by this applicant

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Seprafilm Adhesion Barrier (P950034/S059)Baxter Healthcare Corporation2024-12-19
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