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FDA 510(k)

MANAN NEPHROSTOMY DRAINAGE CATHETER

K-Number: K953547 · 1995-08-30

ApplicantManan Medical Products, Inc.
Decision Date1995-08-30
Product CodeLJE
DecisionSubstantially Equivalent

Device Summary

MANAN NEPHROSTOMY DRAINAGE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Manan Medical Products, Inc.. It received FDA 510(k) clearance on 1995-08-30 under 510(k) number K953547. The device is classified under product code LJE. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MANAN NEPHROSTOMY DRAINAGE CATHETER?

MANAN NEPHROSTOMY DRAINAGE CATHETER is a medical device that received FDA 510(k) clearance on 1995-08-30. The listed applicant is Manan Medical Products, Inc.. The 510(k) number is K953547.

When did MANAN NEPHROSTOMY DRAINAGE CATHETER receive FDA 510(k) clearance?

MANAN NEPHROSTOMY DRAINAGE CATHETER received FDA 510(k) clearance on 1995-08-30, under 510(k) number K953547.

Who is the listed applicant for MANAN NEPHROSTOMY DRAINAGE CATHETER?

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

What is the FDA product code for MANAN NEPHROSTOMY DRAINAGE CATHETER?

The FDA product code for MANAN NEPHROSTOMY DRAINAGE CATHETER is LJE.

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Other records listing Manan Medical Products, 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.

K052802MANAN BIO-CUT SOFT TISSUE BIOPSY NEEDLEK011209MANAN SPRITACRE SPINAL NEEDLESK983620MANAN SPINAL NEEDLESK980536EPIDURAL NEEDLEK981386MANAN BLUNT NEEDLEK980211MRI CHIBA,SPINAL,BREAST LOCALIZATION,AUTOMATIC CUTTING NEEDLES

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Related Devices (Code: LJE)

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.

K250448Disposable Percutaneous Nephrostomy Dilatation KitShenzhen Trious Medical Technology Co., Ltd.K222705Introducer NeedleYoucare Technology Co.,Ltd. (Wuhan)K211911Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture SetsColoplast Corp.K201165In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz SheathColoplast Corp.K191498Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-LocCook IncorporatedK190903Lawson Retrograde Nephrostomy Wire Puncture SetCook Incorporated

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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