Atlas FDA

TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT

FDA 510(k) clearance K122576 · decided 2013-01-11

Clearance details

K-number
K122576
Device name
TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT
Applicant
Stryker Neurovascular
Decision
Substantially Equivalent
Date received
2012-08-23
Decision date
2013-01-11
Days to decision
141 days
Clearance type
Traditional
Product code
MJN
Device class
2
Regulation number
870.4450
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Fremont, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Stryker brand COMPLIANT 4MM X 10MM, Catalog Number: M003SRC04100; Product is manufactured recall (Z-0505-2014)Stryker Neurovascular2013-12-13
Stryker brand COMPLIANT 4MM X 15MM, Catalog Number: M003SRC04150; Product is manufactured recall (Z-0506-2014)Stryker Neurovascular2013-12-13
Stryker brand COMPLIANT 4MM X 20MM, Catalog Number: M003SRC04200; Product is manufactured recall (Z-0507-2014)Stryker Neurovascular2013-12-13
Stryker brand COMPLIANT 4MM X 30MM, Catalog Number: M003SRC04300; Product is manufactured recall (Z-0508-2014)Stryker Neurovascular2013-12-13
Stryker brand COMPLIANT 5MM X 15MM, Catalog Number: M003SRC05150; Product is manufactured recall (Z-0509-2014)Stryker Neurovascular2013-12-13
Stryker brand COMPLIANT 5MM X 30MM, Catalog Number: M003SRC05300; Product is manufactured recall (Z-0510-2014)Stryker Neurovascular2013-12-13
Stryker brand SUPER COMPLIANT 4MM X 7MM, Catalog Number: M003SSC04070; Product is manufact recall (Z-0511-2014)Stryker Neurovascular2013-12-13
Stryker brand SUPER COMPLIANT 7MM X 15MM, Catalog Number: M003SSC07150; Product is manufac recall (Z-0512-2014)Stryker Neurovascular2013-12-13

PMA approvals by this applicant

RecordFirmDate
Surpass Streamline Flow Diverter (P170024/S024)Stryker Neurovascular2025-08-20
Neuroform Atlas® Stent System (P180031/S006)Stryker Neurovascular2025-06-24
Surpass Streamline Flow Diverter (P170024/S023)Stryker Neurovascular2025-05-30
Neuroform Atlas Stent System (P180031/S011)Stryker Neurovascular2025-05-09
Surpass Elite Flow Diverter System (P170024/S022)Stryker Neurovascular2025-02-12
Neuroform Atlas Stent System (P180031/S010)Stryker Neurovascular2024-12-09
Neuroform Atlas Stent System (P180031/S009)Stryker Neurovascular2024-11-18
Surpass Elite Flow Diverter System (P170024/S018)Stryker Neurovascular2024-10-16