FDA 510(k)

SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT

K-Number: K022620 · 2002-10-11

Decision Date2002-10-11

Product CodeFKA

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT is the device name listed in this FDA 510(k) record. The listed applicant is Spire Biomedical, Inc.. It received FDA 510(k) clearance on 2002-10-11 under 510(k) number K022620. The device is classified under product code FKA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT?

SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT is a medical device that received FDA 510(k) clearance on 2002-10-11. The listed applicant is Spire Biomedical, Inc.. The 510(k) number is K022620.

When did SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT receive FDA 510(k) clearance?

SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT received FDA 510(k) clearance on 2002-10-11, under 510(k) number K022620.

Who is the listed applicant for SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT?

The FDA 510(k) record lists Spire Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT?

The FDA product code for SHEATHLESS ACCESSORY KIT, MODELS XRIK24, XRIK28, XRIK32, XRIK36, XRIK40 AND XRIKRT is FKA.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.