Atlas FDA

CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC...

FDA 510(k) clearance K111117 · decided 2011-06-30

Clearance details

K-number
K111117
Device name
CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC...
Applicant
Teleflexmedical, Inc.
Decision
Unknown
Date received
2011-04-21
Decision date
2011-06-30
Days to decision
70 days
Clearance type
Special
Product code
MSD
Device class
2
Regulation number
876.5540
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Reading, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I recall (Z-2156-2026)ARROW INTERNATIONAL, LLC2026-05-13
Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15 recall (Z-2158-2026)ARROW INTERNATIONAL, LLC2026-05-13
NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-1519 recall (Z-2159-2026)ARROW INTERNATIONAL, LLC2026-05-13
The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade He recall (Z-1007-2015)Arrow International Inc2015-01-22