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FDA 510(k)

TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001

K-Number: K000416 · 2000-05-08

ApplicantRetinalabs.Com
Decision Date2000-05-08
Product CodeMPA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001 is the device name listed in this FDA 510(k) record. The listed applicant is Retinalabs.Com. It received FDA 510(k) clearance on 2000-05-08 under 510(k) number K000416. The device is classified under product code MPA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001?

TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001 is a medical device that received FDA 510(k) clearance on 2000-05-08. The listed applicant is Retinalabs.Com. The 510(k) number is K000416.

When did TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001 receive FDA 510(k) clearance?

TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001 received FDA 510(k) clearance on 2000-05-08, under 510(k) number K000416.

Who is the listed applicant for TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001?

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

What is the FDA product code for TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001?

The FDA product code for TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001 is MPA.

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 Retinalabs.Com 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.

K003036TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025K000418PDT DOSECALCULATOR, MODEL 80000K000457VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIESK000420SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003

Related Devices (Code: MPA)

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.

K253468Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)Nova Eye, Inc.K242184Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);Alcon Laboratories, Inc.K233653Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)Peregrine Surgical, LLCK221872ITrack Advance Canaloplasty Microcatheter with Advanced Delivery SystemNova Eye Inc. (Business Name Nova Eye Medical)K202670Nam illumination probe with chopperOculight , Ltd.K080067ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETERIscience Interventional

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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