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FDA 510(k)

FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4)

K-Number: K812981 · 1981-11-06

ApplicantVenusa , Ltd.
Decision Date1981-11-06
Product CodeFPK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4) is the device name listed in this FDA 510(k) record. The listed applicant is Venusa , Ltd.. It received FDA 510(k) clearance on 1981-11-06 under 510(k) number K812981. 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 FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4)?

FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4) is a medical device that received FDA 510(k) clearance on 1981-11-06. The listed applicant is Venusa , Ltd.. The 510(k) number is K812981.

When did FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4) receive FDA 510(k) clearance?

FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4) received FDA 510(k) clearance on 1981-11-06, under 510(k) number K812981.

Who is the listed applicant for FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4)?

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

What is the FDA product code for FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4)?

The FDA product code for FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4) is FPK.

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Other records listing Venusa , Ltd. 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.

K994429VENUSA, LTD. EXTENSION SET WITH FILTERK981683HUBER NEEDLE INFUSION SET MODEL #20G01 & Y-SITE MODEL #20G01YK905518BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SETK851975ENTERAL FEEDING BAG, 1000 ML, & TUBING SETK843692FLU VEN I.V. SET 0153-C PERMA-SETK842088FLU MET 2

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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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