Diatek Cannon-Catheter, Model CC5500

FDA 510(k) K022662 · Arrow Intl., Inc.

Unknown

510(k) numberK022662

Submission

Device name
Diatek Cannon-Catheter, Model CC5500
Applicant
Arrow Intl., Inc.
Reading, PA, US
Received
August 9, 2002
Decision date
May 9, 2003
Decision
Unknown (SESK)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MSD – Catheter, Hemodialysis, Implanted
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5540
Specialty
Gastroenterology, Urology
Implant
Yes
Life-sustaining
Yes

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K182443Pristine Hemodialysis CatheterMSD · Traditional Pristine Access Technologies , Ltd.05/31/2019SE

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Questions and answers

When was Diatek Cannon-Catheter, Model CC5500 cleared by the FDA?

Diatek Cannon-Catheter, Model CC5500 (K022662) received a 510(k) decision of Unknown on May 9, 2003, 273 days after the submission was received.

What is the product code of K022662?

The FDA product code is MSD – Catheter, Hemodialysis, Implanted, a Class II (moderate risk) device regulated under 21 CFR 876.5540.