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FDA 510(k)

BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET

K-Number: K905518 · 1991-06-21

ApplicantVenusa , Ltd.
Decision Date1991-06-21
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET is the device name listed in this FDA 510(k) record. The listed applicant is Venusa , Ltd.. It received FDA 510(k) clearance on 1991-06-21 under 510(k) number K905518. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET?

BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET is a medical device that received FDA 510(k) clearance on 1991-06-21. The listed applicant is Venusa , Ltd.. The 510(k) number is K905518.

When did BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET receive FDA 510(k) clearance?

BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET received FDA 510(k) clearance on 1991-06-21, under 510(k) number K905518.

Who is the listed applicant for BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET?

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 BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET?

The FDA product code for BERLEX BOLUS/INFUSION(TM) INTRAVENOUS ADMIN SET is IZI.

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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 #20G01YK851975ENTERAL FEEDING BAG, 1000 ML, & TUBING SETK843692FLU VEN I.V. SET 0153-C PERMA-SETK842088FLU MET 2K812981FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4)

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Related Devices (Code: IZI)

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.

K261037780 nm SPY Portable Handheld Imaging (SPY-PHI) SystemStryker EndoscopyK253181SURGIMAGE SIM 1000H Fluorescence Imaging PlatformSurgimage CorporationK243645IC-Flow™ Imaging System 2.0Diagnostic Green GmbHK243077Affirm 800Digital Surgery Systems, Inc. (D.B.A True Digital Surgery)K231986Modus IRSynaptive Medical, Inc.K234090EXPLORER AIR® II (8001, 8002, 8003); EXPLORER AIR® Sterile Drape (8004)Surgvision GmbH

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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