FDA 510(k)

MINIFILTER HEMOFILTER

K-Number: K853510 · 1985-09-12

Decision Date1985-09-12

Product CodeKDI

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

MINIFILTER HEMOFILTER is the device name listed in this FDA 510(k) record. The listed applicant is Amicon, Inc.. It received FDA 510(k) clearance on 1985-09-12 under 510(k) number K853510. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MINIFILTER HEMOFILTER?

MINIFILTER HEMOFILTER is a medical device that received FDA 510(k) clearance on 1985-09-12. The listed applicant is Amicon, Inc.. The 510(k) number is K853510.

When did MINIFILTER HEMOFILTER receive FDA 510(k) clearance?

MINIFILTER HEMOFILTER received FDA 510(k) clearance on 1985-09-12, under 510(k) number K853510.

Who is the listed applicant for MINIFILTER HEMOFILTER?

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

What is the FDA product code for MINIFILTER HEMOFILTER?

The FDA product code for MINIFILTER HEMOFILTER is KDI.

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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.