Atlas FDA

LATIS GRAFT CLEANING CATHETER

FDA 510(k) clearance K973465 · decided 1998-02-19

Clearance details

K-number
K973465
Device name
LATIS GRAFT CLEANING CATHETER
Applicant
Applied Medical Resources
Decision
Substantially Equivalent
Date received
1997-09-12
Decision date
1998-02-19
Days to decision
160 days
Clearance type
Traditional
Product code
DXE
Device class
2
Regulation number
870.5150
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Launa Hills, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, recall (Z-1848-2020)Applied Medical Resources Corp2020-05-07