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FDA 510(k)

MODIFIED HOLLOW FIBERS USED IN DIAFILTER HEMOFIL.

K-Number: K873887 · 1987-12-09

ApplicantW.R. Grace & Co.-Conn.
Decision Date1987-12-09
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFIED HOLLOW FIBERS USED IN DIAFILTER HEMOFIL. is the device name listed in this FDA 510(k) record. The listed applicant is W.R. Grace & Co.-Conn.. It received FDA 510(k) clearance on 1987-12-09 under 510(k) number K873887. 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 MODIFIED HOLLOW FIBERS USED IN DIAFILTER HEMOFIL.?

MODIFIED HOLLOW FIBERS USED IN DIAFILTER HEMOFIL. is a medical device that received FDA 510(k) clearance on 1987-12-09. The listed applicant is W.R. Grace & Co.-Conn.. The 510(k) number is K873887.

When did MODIFIED HOLLOW FIBERS USED IN DIAFILTER HEMOFIL. receive FDA 510(k) clearance?

MODIFIED HOLLOW FIBERS USED IN DIAFILTER HEMOFIL. received FDA 510(k) clearance on 1987-12-09, under 510(k) number K873887.

Who is the listed applicant for MODIFIED HOLLOW FIBERS USED IN DIAFILTER HEMOFIL.?

The FDA 510(k) record lists W.R. Grace & Co.-Conn. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED HOLLOW FIBERS USED IN DIAFILTER HEMOFIL.?

The FDA product code for MODIFIED HOLLOW FIBERS USED IN DIAFILTER HEMOFIL. is KDI.

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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing W.R. Grace & Co.-Conn. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K860804MEDICAL ADHESIVE TAPE

Related Devices (Code: KDI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261267Careflux H60;Careflux H70;Careflux V500Fresenius Medical Care Renal Therapies Group, LLCK252377NxStage System One with NxViewFresenius Medical Care Renal Therapies Group, LLCK260533ELISIO™-HNipro Medical CorporationK252459multiFlux 130 (F00013123); multiFlux 160 (F00013124)Fresenius Medical Care Renal Therapies Group, LLCK253412Tablo Hemodialysis System (PN-0008000, PN-0006000U)Outset Medical, Inc.K253518FX CorAL 40; FX CorAL 50Fresenius Medical Care Renal Therapies Group, LLC

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.

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