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FDA 510(k)

VITREORETINAL INFUSION CANNULA

K-Number: K904074 · 1991-02-26

ApplicantVisitec Co.
Decision Date1991-02-26
Product CodeHMX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VITREORETINAL INFUSION CANNULA is the device name listed in this FDA 510(k) record. The listed applicant is Visitec Co.. It received FDA 510(k) clearance on 1991-02-26 under 510(k) number K904074. 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 VITREORETINAL INFUSION CANNULA?

VITREORETINAL INFUSION CANNULA is a medical device that received FDA 510(k) clearance on 1991-02-26. The listed applicant is Visitec Co.. The 510(k) number is K904074.

When did VITREORETINAL INFUSION CANNULA receive FDA 510(k) clearance?

VITREORETINAL INFUSION CANNULA received FDA 510(k) clearance on 1991-02-26, under 510(k) number K904074.

Who is the listed applicant for VITREORETINAL INFUSION CANNULA?

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

What is the FDA product code for VITREORETINAL INFUSION CANNULA?

The FDA product code for VITREORETINAL INFUSION CANNULA is HMX.

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Other records listing Visitec Co. 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.

K953394VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}K945114VISITEC SCLERAL PLUGK945738VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPEK945172VISITEC SILICONE RETINAL IMPLANTS/EXPLANTSK942234VISITEC PRECISE-POINTK934269FIBEROPTIC ILLUMINATED INSTRUMENTS

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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.K000457VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIESRetinalabs.ComK970873ENDOSOFT 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.

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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