Atlas FDA

Reprocessed ViewFlex Xtra ICE Catheter

FDA 510(k) clearance K182238 · decided 2019-05-08

Clearance details

K-number
K182238
Device name
Reprocessed ViewFlex Xtra ICE Catheter
Applicant
Stryker Sustainability Solutions
Decision
Substantially Equivalent
Date received
2018-08-20
Decision date
2019-05-08
Days to decision
261 days
Clearance type
Traditional
Product code
OWQ
Device class
2
Regulation number
870.1200
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Tempe, AZ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Cardiovascular Reprocessed ViewFlex Xtra ICE Catheter, REF D087031, OM St. Jude Medical, S recall (Z-2113-2020)Stryker Sustainability Solutions2020-06-01