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FDA 510(k)

3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100

K-Number: K900605 · 1990-03-06

ApplicantPossis Medical, Inc.
Decision Date1990-03-06
Product CodeDTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100 is the device name listed in this FDA 510(k) record. The listed applicant is Possis Medical, Inc.. It received FDA 510(k) clearance on 1990-03-06 under 510(k) number K900605. The device is classified under product code DTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100?

3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100 is a medical device that received FDA 510(k) clearance on 1990-03-06. The listed applicant is Possis Medical, Inc.. The 510(k) number is K900605.

When did 3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100 receive FDA 510(k) clearance?

3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100 received FDA 510(k) clearance on 1990-03-06, under 510(k) number K900605.

Who is the listed applicant for 3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100?

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

What is the FDA product code for 3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100?

The FDA product code for 3.2-5MM UNIPOLAR LEAD UPSIZING KIT, MODEL AK 100 is DTD.

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Related Devices (Code: DTD)

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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.

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