FDA 510(k)

GAMGRO ENGSTROM Y FILTER WITH EDITH FLEX (1500 F), EDIT 500, 1000, 2600 AND Y FILTER PACKAGED ALONE

K-Number: K945543 · 1994-11-29

ApplicantIntersect Medical Products, Inc.

Decision Date1994-11-29

Product CodeCAH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

GAMGRO ENGSTROM Y FILTER WITH EDITH FLEX (1500 F), EDIT 500, 1000, 2600 AND Y FILTER PACKAGED ALONE is the device name listed in this FDA 510(k) record. The listed applicant is Intersect Medical Products, Inc.. It received FDA 510(k) clearance on 1994-11-29 under 510(k) number K945543. The device is classified under product code CAH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMGRO ENGSTROM Y FILTER WITH EDITH FLEX (1500 F), EDIT 500, 1000, 2600 AND Y FILTER PACKAGED ALONE?

GAMGRO ENGSTROM Y FILTER WITH EDITH FLEX (1500 F), EDIT 500, 1000, 2600 AND Y FILTER PACKAGED ALONE is a medical device that received FDA 510(k) clearance on 1994-11-29. The listed applicant is Intersect Medical Products, Inc.. The 510(k) number is K945543.

When did GAMGRO ENGSTROM Y FILTER WITH EDITH FLEX (1500 F), EDIT 500, 1000, 2600 AND Y FILTER PACKAGED ALONE receive FDA 510(k) clearance?

GAMGRO ENGSTROM Y FILTER WITH EDITH FLEX (1500 F), EDIT 500, 1000, 2600 AND Y FILTER PACKAGED ALONE received FDA 510(k) clearance on 1994-11-29, under 510(k) number K945543.

Who is the listed applicant for GAMGRO ENGSTROM Y FILTER WITH EDITH FLEX (1500 F), EDIT 500, 1000, 2600 AND Y FILTER PACKAGED ALONE?

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

What is the FDA product code for GAMGRO ENGSTROM Y FILTER WITH EDITH FLEX (1500 F), EDIT 500, 1000, 2600 AND Y FILTER PACKAGED ALONE?

The FDA product code for GAMGRO ENGSTROM Y FILTER WITH EDITH FLEX (1500 F), EDIT 500, 1000, 2600 AND Y FILTER PACKAGED ALONE is CAH.

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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.