Atlas FDA

CANNON II PLUS

FDA 510(k) clearance K040078 · decided 2004-02-13

Clearance details

K-number
K040078
Device name
CANNON II PLUS
Applicant
Arrow International, Inc.
Decision
Unknown
Date received
2004-01-14
Decision date
2004-02-13
Days to decision
30 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
Cannon" II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 19cm, CS-15242-SP, Intend recall (Z-2252-2008)Arrow International Inc2008-09-17
Cannon" II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 23cm, CS-15282-SP, Intend recall (Z-2253-2008)Arrow International Inc2008-09-17
Cannon" II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 27cm, CS-15322-SP, Intend recall (Z-2254-2008)Arrow International Inc2008-09-17
Cannon" II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 31cm, CS-15362-SP, Intend recall (Z-2255-2008)Arrow International Inc2008-09-17
Cannon" II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 50cm, CS-15552-SP, Intend recall (Z-2256-2008)Arrow International Inc2008-09-17
Cannon II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 19cm, CS-15242-VSP, Intend recall (Z-2257-2008)Arrow International Inc2008-09-17
Cannon II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 23cm, CS-15282-VSP, Intend recall (Z-2258-2008)Arrow International Inc2008-09-17
Cannon II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 27cm, CS-15322-VSP, Intend recall (Z-2259-2008)Arrow International Inc2008-09-17
Cannon II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 31cm, CS-15362-VSP, Intend recall (Z-2260-2008)Arrow International Inc2008-09-17
Cannon II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 50cm, CS-15552-VSP, Intend recall (Z-2261-2008)Arrow International Inc2008-09-17
Cannon II Plus, Hemodialysis Catherization Set, Long-Term Access. Catheter Length, Cuff to recall (Z-2262-2008)Arrow International Inc2008-09-17
Cannon II Plus, Hemodialysis Catherization Set, Long-Term Access. Catheter Length, Cuff to recall (Z-2263-2008)Arrow International Inc2008-09-17
Cannon II Plus, Hemodialysis Catherization Set, Long-Term Access. Catheter Length, Cuff to recall (Z-2264-2008)Arrow International Inc2008-09-17
Cannon II Plus, Hemodialysis Catherization Set, Long-Term Access. Catheter Length, Cuff to recall (Z-2265-2008)Arrow International Inc2008-09-17
Cannon II Plus, Hemodialysis Catherization Set, Long-Term Access. Catheter Length, Cuff to recall (Z-2266-2008)Arrow International Inc2008-09-17
Cannon II Plus, Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, C recall (Z-2267-2008)Arrow International Inc2008-09-17
Cannon II Plus, Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, C recall (Z-2268-2008)Arrow International Inc2008-09-17
Cannon II Plus, Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, C recall (Z-2269-2008)Arrow International Inc2008-09-17
Cannon II Plus, Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, C recall (Z-2270-2008)Arrow International Inc2008-09-17