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FDA 510(k)

HEMO-PROCESSING SYSTEM

K-Number: K830487 · 1983-04-28

ApplicantSartorius Filters, Inc.
Decision Date1983-04-28
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEMO-PROCESSING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sartorius Filters, Inc.. It received FDA 510(k) clearance on 1983-04-28 under 510(k) number K830487. 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 HEMO-PROCESSING SYSTEM?

HEMO-PROCESSING SYSTEM is a medical device that received FDA 510(k) clearance on 1983-04-28. The listed applicant is Sartorius Filters, Inc.. The 510(k) number is K830487.

When did HEMO-PROCESSING SYSTEM receive FDA 510(k) clearance?

HEMO-PROCESSING SYSTEM received FDA 510(k) clearance on 1983-04-28, under 510(k) number K830487.

Who is the listed applicant for HEMO-PROCESSING SYSTEM?

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

What is the FDA product code for HEMO-PROCESSING SYSTEM?

The FDA product code for HEMO-PROCESSING SYSTEM is KDI.

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Other records listing Sartorius Filters, Inc. 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.

K851816SARTORIUS MINISART FH 16534K851818SARTORIUS MINI SART FH 16592K851817SARTORIUS MINI-SART FH 16555K850435SARTORIUS AQUASART SM 40035 - DIALYSATE SYSK844504SARTORIUS MINISART SM 16596HYK823132SARTOPHOR SYSTEM FOR ELECTROPHORESIS

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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

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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