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FDA 510(k)

CPR URETHRAL CATHETER TRAY

K-Number: K960215 · 1996-04-01

ApplicantCustom Pack Reliability
Decision Date1996-04-01
Product CodeFCM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CPR URETHRAL CATHETER TRAY is the device name listed in this FDA 510(k) record. The listed applicant is Custom Pack Reliability. It received FDA 510(k) clearance on 1996-04-01 under 510(k) number K960215. The device is classified under product code FCM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CPR URETHRAL CATHETER TRAY?

CPR URETHRAL CATHETER TRAY is a medical device that received FDA 510(k) clearance on 1996-04-01. The listed applicant is Custom Pack Reliability. The 510(k) number is K960215.

When did CPR URETHRAL CATHETER TRAY receive FDA 510(k) clearance?

CPR URETHRAL CATHETER TRAY received FDA 510(k) clearance on 1996-04-01, under 510(k) number K960215.

Who is the listed applicant for CPR URETHRAL CATHETER TRAY?

The FDA 510(k) record lists Custom Pack Reliability as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CPR URETHRAL CATHETER TRAY?

The FDA product code for CPR URETHRAL CATHETER TRAY is FCM.

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 Custom Pack Reliability 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.

K960205CPR TRACHEOTOMY CARE TRAYK960243CPR C-SECTION DELIVERY PACKK960239CPR D & C TRAYK960216CPR SUCTION CATHETER KITK960210CPR ORTHO HAND PACKK960206CPR DRESSING CHANGE TRAY

View all 21 devices →

Related Devices (Code: FCM)

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.

K254076BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter KitC.R. Bard, Inc.K250891Cure Catheter Insertion Kit (K1); Cure Catheter Insertion Kit (K2); Cure Catheter Insertion Kit (K2-90); Cure Catheter Insertion Kit (K3); Cure Hydrophilic Catheter Kit (HM12UK); Cure Hydrophilic Catheter Kit (HM14UK); Cure Hydrophilic Catheter Kit (HM16UK); Cure Pocket Catheter Kit (M14UK); Cure Catheter Closed System Kit (CS8); Cure Catheter Closed System Kit (CS10); Cure Catheter Closed System Kit (CS12); Cure Catheter Closed System Kit (CS14); Cure Catheter Closed System Kit (CS14CConvatec LimitedK223821Self-Cath Closed SystemColoplastK082831AMSELF CLOSED CATHETERIZATION SYSTEMAmsino International, Inc.K070939SELF-CATH CS CLOSED URINARY CATHETERIZATION SYSTEMColoplast Manufacturing Us, LLCK070048GUARDIAN CATHETER-INFANT URINARY COLLECTION KITMarian Medical, 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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