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FDA 510(k)

RED COLOR-TINTED TUBING

K-Number: K832758 · 1983-09-12

ApplicantCustom Medical, Inc.
Decision Date1983-09-12
Product CodeFPK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RED COLOR-TINTED TUBING is the device name listed in this FDA 510(k) record. The listed applicant is Custom Medical, Inc.. It received FDA 510(k) clearance on 1983-09-12 under 510(k) number K832758. The device is classified under product code FPK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RED COLOR-TINTED TUBING?

RED COLOR-TINTED TUBING is a medical device that received FDA 510(k) clearance on 1983-09-12. The listed applicant is Custom Medical, Inc.. The 510(k) number is K832758.

When did RED COLOR-TINTED TUBING receive FDA 510(k) clearance?

RED COLOR-TINTED TUBING received FDA 510(k) clearance on 1983-09-12, under 510(k) number K832758.

Who is the listed applicant for RED COLOR-TINTED TUBING?

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

What is the FDA product code for RED COLOR-TINTED TUBING?

The FDA product code for RED COLOR-TINTED TUBING is FPK.

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 Medical, 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.

K905002SINGLE USE MANUAL RESUSCITATORSK830182CUSTOM IV SET

Related Devices (Code: FPK)

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.

K131517MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBINGMedrad, Inc. / Bayer Medical Care, Inc.K063114DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVESCoeur, Inc.K063239LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526Hospira, Inc.K052431MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1Medtronic MinimedK041178EMPOWER TRANSFER SET, (CAT. NO. 7725)E-Z-Em, Inc.K031808MEDRAD SWABBABLE VALVE TRANSFER SETMedrad, 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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