FDA 510(k)

CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2

K-Number: K090613 · 2009-07-01

ApplicantSt. Jude Medical, Cardiac Rhythm Management Divisi

Decision Date2009-07-01

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2 is the device name listed in this FDA 510(k) record. The listed applicant is St. Jude Medical, Cardiac Rhythm Management Divisi. It received FDA 510(k) clearance on 2009-07-01 under 510(k) number K090613. 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 SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2?

CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2 is a medical device that received FDA 510(k) clearance on 2009-07-01. The listed applicant is St. Jude Medical, Cardiac Rhythm Management Divisi. The 510(k) number is K090613.

When did CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2 receive FDA 510(k) clearance?

CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2 received FDA 510(k) clearance on 2009-07-01, under 510(k) number K090613.

Who is the listed applicant for CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2?

The FDA 510(k) record lists St. Jude Medical, Cardiac Rhythm Management Divisi as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2?

The FDA product code for CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2 is DQY.

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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.