Atlas FDA

RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT

FDA 510(k) clearance K110051 · decided 2012-02-02

Clearance details

K-number
K110051
Device name
RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT
Applicant
Great Batch Medical
Decision
Substantially Equivalent
Date received
2011-01-07
Decision date
2012-02-02
Days to decision
391 days
Clearance type
Traditional
Product code
DYB
Device class
2
Regulation number
870.1340
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Plymouth, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Cordis a Johnson & Johnson Company, RadialSource Spring Wire Transradial Access Kit. Manuf recall (Z-1608-2013)Greatbatch Medical2013-06-27

PMA approvals by this applicant

RecordFirmDate
Myopore® Sutureless Myocardial Pacing Lead (P130012/S016)Great Batch Medical2024-04-19
Myopore Sutureless Myocardial Pacing Lead (P130012/S015)Great Batch Medical2023-12-13
Myopore® Sutureless Myocardial Pacing Lead (P130012/S014)Great Batch Medical2023-07-07
Myopore® Sutureless Myocardial Pacing Lead (P130012/S013)Great Batch Medical2023-02-07
Myopore Sutureless Myocardial Pacing Lead (P130012/S010)Great Batch Medical2022-12-12
Myopore® Sutureless Myocardial Pacing Lead (P130012/S009)Great Batch Medical2022-10-05
Myopore Sutureless Myocardial Pacing Lead (P130012/S007)Great Batch Medical2019-07-15
Myopore Sutureless Myocardial Pacing Lead (P130012/S008)Great Batch Medical2019-07-03