Vessel Dilators

FDA 510(k) K910502 · Akcess Medical Products, Inc.

Substantially Equivalent

510(k) numberK910502

Submission

Device name
Vessel Dilators
Applicant
Akcess Medical Products, Inc.
New Brunswick, NJ, US
Received
February 5, 1991
Decision date
April 29, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
FKA – Dilator, Vessel
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5540
Specialty
Gastroenterology, Urology

Other 510(k)s with product code FKA

510(k)DeviceApplicantDecision
K022620Sheathless Accessory Kit, Models XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 and XrikrtFKA · Traditional Spire Biomedical, Inc.10/11/2002SE
K914210Vas-Cath Dualator(Tm) Vessel DilatorFKA · Traditional Vas-Cath, Inc.07/01/1993SE

More from Vas-Cath, Inc.

510(k)DeviceDecision
K926374Silicone Catheter Repair KitsKOC · Traditional 10/07/1994SESK
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

Questions and answers

When was Vessel Dilators cleared by the FDA?

Vessel Dilators (K910502) received a 510(k) decision of Substantially Equivalent on April 29, 1991, 83 days after the submission was received.

What is the product code of K910502?

The FDA product code is FKA – Dilator, Vessel, a Class II (moderate risk) device regulated under 21 CFR 876.5540.