Silicone Catheter Repair Kits

FDA 510(k) K926374 · Akcess Medical Products, Inc.

Unknown

510(k) numberK926374

Submission

Device name
Silicone Catheter Repair Kits
Applicant
Akcess Medical Products, Inc.
New Brunswick, NJ, US
Received
December 22, 1992
Decision date
October 7, 1994
Decision
Unknown (SESK)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KOC – Accessories, Blood Circuit, Hemodialysis
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5820
Specialty
Gastroenterology, Urology
Life-sustaining
Yes

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More from Fresenius Medical Care Renal Therapies Group, LLC

510(k)DeviceDecision
K925819AKCESS0CATH KitLFJ · Traditional 08/02/1994SE
K925818Akcess-CathLFJ · Traditional 04/05/1994SE
K930630Right Atrial CatheterLJS · Traditional 02/07/1994SN
K931120Coaxial Acute CatheterLFJ · Traditional 01/14/1994SE
K920634Splittable Sheath Introducer SetLFJ · Traditional 01/14/1994SE
K914936Continuous Arteriovenous Hemofiltration Cath SetLFK · Traditional 04/23/1992SESK
K920331Right Atrial Catheter KitsDQY · Traditional 04/22/1992SESK
K914826Akcess-Cath KitLFJ · Traditional 04/10/1992SESK
K915215Continuous Arteriovenous Hemofiltration Cath. KitsLFK · Traditional 03/27/1992SESK
K911333Right Atrial CathetersDQY · Traditional 09/23/1991SE

Questions and answers

When was Silicone Catheter Repair Kits cleared by the FDA?

Silicone Catheter Repair Kits (K926374) received a 510(k) decision of Unknown on October 7, 1994, 654 days after the submission was received.

What is the product code of K926374?

The FDA product code is KOC – Accessories, Blood Circuit, Hemodialysis, a Class II (moderate risk) device regulated under 21 CFR 876.5820.