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FDA 510(k)

VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES

K-Number: K000457 · 2000-05-09

ApplicantRetinalabs.Com
Decision Date2000-05-09
Product CodeHMX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Retinalabs.Com. It received FDA 510(k) clearance on 2000-05-09 under 510(k) number K000457. The device is classified under product code HMX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES?

VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES is a medical device that received FDA 510(k) clearance on 2000-05-09. The listed applicant is Retinalabs.Com. The 510(k) number is K000457.

When did VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES receive FDA 510(k) clearance?

VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES received FDA 510(k) clearance on 2000-05-09, under 510(k) number K000457.

Who is the listed applicant for VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES?

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 VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES?

The FDA product code for VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES is HMX.

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 80000K000420SILICONE OIL EXPRESS (INFUSION PAK), MODELS 10000, 10001, 10002, 10003K000416TRANSPAK (VITREORETINAL INFUSION PAK), MODELS 90000, 90001

Related Devices (Code: HMX)

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.

K010305WEISS RETINAL CANNULAMicron Surgical, Inc.K970873ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)American Medical Devices, Inc.K943932STERISEAL OPHTHALMIC CANNULAPharma-Plast, Ltd.K942403INFUSION CANNULAMicrosurgical Technology, Inc.K934844INTER TIP TMicrosurgical Technology, Inc.K930113KIRWAN IRRIGATION/ASPIRATION HANDPIECEKirwan Surgical Products, 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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