FDA 510(k)

CPS AIM Universal II Slittable Inner Catheter

K-Number: K221750 · 2022-06-30

Decision Date2022-06-30

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CPS AIM Universal II Slittable Inner Catheter is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2022-06-30 under 510(k) number K221750. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CPS AIM Universal II Slittable Inner Catheter?

CPS AIM Universal II Slittable Inner Catheter is a medical device that received FDA 510(k) clearance on 2022-06-30. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K221750.

When did CPS AIM Universal II Slittable Inner Catheter receive FDA 510(k) clearance?

CPS AIM Universal II Slittable Inner Catheter received FDA 510(k) clearance on 2022-06-30, under 510(k) number K221750.

Who is the listed applicant for CPS AIM Universal II Slittable Inner Catheter?

The FDA 510(k) record lists ABBOTT MEDICAL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CPS AIM Universal II Slittable Inner Catheter?

The FDA product code for CPS AIM Universal II Slittable Inner Catheter is DQY.

Other records listing ABBOTT MEDICAL as applicant

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Official Source

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