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FDA 510(k)

L.T.C. 1000 URINARY DRAINAGE BAG

K-Number: K895957 · 1989-10-24

ApplicantIntl. Medical Marketing, Inc.
Decision Date1989-10-24
Product CodeKNX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

L.T.C. 1000 URINARY DRAINAGE BAG is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Medical Marketing, Inc.. It received FDA 510(k) clearance on 1989-10-24 under 510(k) number K895957. 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 L.T.C. 1000 URINARY DRAINAGE BAG?

L.T.C. 1000 URINARY DRAINAGE BAG is a medical device that received FDA 510(k) clearance on 1989-10-24. The listed applicant is Intl. Medical Marketing, Inc.. The 510(k) number is K895957.

When did L.T.C. 1000 URINARY DRAINAGE BAG receive FDA 510(k) clearance?

L.T.C. 1000 URINARY DRAINAGE BAG received FDA 510(k) clearance on 1989-10-24, under 510(k) number K895957.

Who is the listed applicant for L.T.C. 1000 URINARY DRAINAGE BAG?

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

What is the FDA product code for L.T.C. 1000 URINARY DRAINAGE BAG?

The FDA product code for L.T.C. 1000 URINARY DRAINAGE BAG is KNX.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Intl. Medical Marketing, 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.

K897181L.T.C. PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBEK896621L.T.C. REPLACEMENT GASTROSTOMY TUBEK895824L.T.C. ENTERAL BAG ADMINISTRATION SET W/PUMP SETK895616L.T.C. FEEDING TUBE

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, LLCK9733644L DRAINAGE BAG, 4L BAG FOR PERITONEAL DIALYSIS, 4L URINARY DRAINAGE BAGMaersk Medical A/SK972887MEDLINE 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.

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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