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FDA 510(k)

4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG

K-Number: K973364 · 1998-03-17

ApplicantMaersk Medical A/S
Decision Date1998-03-17
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG is the device name listed in this FDA 510(k) record. The listed applicant is Maersk Medical A/S. It received FDA 510(k) clearance on 1998-03-17 under 510(k) number K973364. The device is classified under product code KNX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG?

4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG is a medical device that received FDA 510(k) clearance on 1998-03-17. The listed applicant is Maersk Medical A/S. The 510(k) number is K973364.

When did 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG receive FDA 510(k) clearance?

4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG received FDA 510(k) clearance on 1998-03-17, under 510(k) number K973364.

Who is the listed applicant for 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG?

The FDA 510(k) record lists Maersk Medical A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG?

The FDA product code for 4L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAG is KNX.

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Other records listing Maersk Medical A/S 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.

K011071PARADIGM QUICK-SET INFUSION SETK002138PARADIGM SILHOUETTE, MODELS MMT-377, 378, 379, 380K990110DISPOSABLE ECG MONITORING ELECTRODES, MODEL 4110, 4140K990113DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4500,4530, 4533, 4539, 4540, AND 4560K990115DISPOSABLE ECG MONITORING ELECTRODES, MODELS, 4420, 4440K990112DISPOSABLE ECG MONITORING ELECTRODES, MODELS 4060, 4610

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Related Devices (Code: KNX)

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.

K110518IBAGFuture Path Medical, LLCK972887MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAGMedline Industries, Inc.K971271BESECURE EXTERNAL URINARY COLLECTION SYSTEMUrology Research Intl., Inc.K971929AMSINO URINARY LEG BAGAmsino Intl., Inc.K971764WELCON HUE-VU URINARY DRAINAGE BAGWelcon, Inc.K964690LIBERTY VALVECleveland Medical Devices, Inc.

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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