Vas-Cath Dualator(Tm) Vessel Dilator

FDA 510(k) K914210 · Vas-Cath, Inc.

Substantially Equivalent

510(k) numberK914210

Submission

Device name
Vas-Cath Dualator(Tm) Vessel Dilator
Applicant
Vas-Cath, Inc.
Mississauga, Ontario, CA
Received
September 19, 1991
Decision date
July 1, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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
K910502Vessel DilatorsFKA · Traditional Akcess Medical Products, Inc.04/29/1991SE

More from Akcess Medical Products, Inc.

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K964881Ultraverse Pta CatheterLIT · Traditional 05/28/1997SE
K970725Opti-Plast XL 5.5 F Pta CatheterLIT · Traditional 05/09/1997SE
K941706Opti-Plast Angioplasty CatheterLIT · Traditional 10/18/1994SE
K925485Vas-Cath Inc. Opti-Plast Angioplasty CatheterLIT · Traditional 03/10/1994SE
K933483Opti-Plast 5F Pta CathetersLIT · Traditional 09/24/1993SE
K914162Vas-Cath Flexxicon 2 Dual Lumen Dialysis CathetersLFJ · Traditional 07/01/1993SE
K914976Opti-Plast 5F Pta Catheters, ModificationLIT · Traditional 01/27/1992SE
K914500Opti-Plast 5F Pta Catheters, ModificationLIT · Traditional 12/31/1991SE

Questions and answers

When was Vas-Cath Dualator(Tm) Vessel Dilator cleared by the FDA?

Vas-Cath Dualator(Tm) Vessel Dilator (K914210) received a 510(k) decision of Substantially Equivalent on July 1, 1993, 651 days after the submission was received.

What is the product code of K914210?

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