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FDA 510(k)

OPHTHALMIC FLUID DISTRIBUTION SETS

K-Number: K923972 · 1992-11-04

ApplicantVisitec Co.
Decision Date1992-11-04
Product CodeFPK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OPHTHALMIC FLUID DISTRIBUTION SETS is the device name listed in this FDA 510(k) record. The listed applicant is Visitec Co.. It received FDA 510(k) clearance on 1992-11-04 under 510(k) number K923972. 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 OPHTHALMIC FLUID DISTRIBUTION SETS?

OPHTHALMIC FLUID DISTRIBUTION SETS is a medical device that received FDA 510(k) clearance on 1992-11-04. The listed applicant is Visitec Co.. The 510(k) number is K923972.

When did OPHTHALMIC FLUID DISTRIBUTION SETS receive FDA 510(k) clearance?

OPHTHALMIC FLUID DISTRIBUTION SETS received FDA 510(k) clearance on 1992-11-04, under 510(k) number K923972.

Who is the listed applicant for OPHTHALMIC FLUID DISTRIBUTION SETS?

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 OPHTHALMIC FLUID DISTRIBUTION SETS?

The FDA product code for OPHTHALMIC FLUID DISTRIBUTION SETS is FPK.

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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: 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

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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