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FDA 510(k)

ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER

K-Number: K130639 · 2013-05-16

ApplicantMaquet Cardiopulmonary, AG
Decision Date2013-05-16
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER 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 2013-05-16 under 510(k) number K130639. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER?

ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER is a medical device that received FDA 510(k) clearance on 2013-05-16. The listed applicant is Maquet Cardiopulmonary, AG. The 510(k) number is K130639.

When did ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER receive FDA 510(k) clearance?

ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER received FDA 510(k) clearance on 2013-05-16, under 510(k) number K130639.

Who is the listed applicant for ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER?

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 ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER?

The FDA product code for ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER is DWF.

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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 40K123288HEMOCONCENTRATOR

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Related Devices (Code: DWF)

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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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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