Sheathless Accessory Kit, Models XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 and Xrikrt

FDA 510(k) K022620 · Spire Biomedical, Inc.

Substantially Equivalent

510(k) numberK022620

Submission

Device name
Sheathless Accessory Kit, Models XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 and Xrikrt
Applicant
Spire Biomedical, Inc.
Bedford, MA, US
Received
August 7, 2002
Decision date
October 11, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary 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
K914210Vas-Cath Dualator(Tm) Vessel DilatorFKA · Traditional Vas-Cath, Inc.07/01/1993SE
K910502Vessel DilatorsFKA · Traditional Akcess Medical Products, Inc.04/29/1991SE

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Questions and answers

When was Sheathless Accessory Kit, Models XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 and Xrikrt cleared by the FDA?

Sheathless Accessory Kit, Models XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 and Xrikrt (K022620) received a 510(k) decision of Substantially Equivalent on October 11, 2002, 65 days after the submission was received.

What is the product code of K022620?

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