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FDA 510(k)

HEMOCONCENTRATOR

K-Number: K123288 · 2013-06-26

ApplicantMaquet Cardiopulmonary, AG
Decision Date2013-06-26
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

HEMOCONCENTRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Maquet Cardiopulmonary, AG. It received FDA 510(k) clearance on 2013-06-26 under 510(k) number K123288. 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 HEMOCONCENTRATOR?

HEMOCONCENTRATOR is a medical device that received FDA 510(k) clearance on 2013-06-26. The listed applicant is Maquet Cardiopulmonary, AG. The 510(k) number is K123288.

When did HEMOCONCENTRATOR receive FDA 510(k) clearance?

HEMOCONCENTRATOR received FDA 510(k) clearance on 2013-06-26, under 510(k) number K123288.

Who is the listed applicant for HEMOCONCENTRATOR?

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

What is the FDA product code for HEMOCONCENTRATOR?

The FDA product code for HEMOCONCENTRATOR is KDI.

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Other records listing Maquet Cardiopulmonary, AG 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.

K133265QUADROX-IR ADULT AND SMALL ADULTK132166VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHTK132829QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORSK131666ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATINGK130300HEATER-COOLER UNIT HCU 40K130639ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER

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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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