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FDA 510(k)

BETTER-VENTER

K-Number: K961594 · 1996-09-05

ApplicantCirculatory Technology, Inc.
Decision Date1996-09-05
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BETTER-VENTER is the device name listed in this FDA 510(k) record. The listed applicant is Circulatory Technology, Inc.. It received FDA 510(k) clearance on 1996-09-05 under 510(k) number K961594. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BETTER-VENTER?

BETTER-VENTER is a medical device that received FDA 510(k) clearance on 1996-09-05. The listed applicant is Circulatory Technology, Inc.. The 510(k) number is K961594.

When did BETTER-VENTER receive FDA 510(k) clearance?

BETTER-VENTER received FDA 510(k) clearance on 1996-09-05, under 510(k) number K961594.

Who is the listed applicant for BETTER-VENTER?

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

What is the FDA product code for BETTER-VENTER?

The FDA product code for BETTER-VENTER is DWF.

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Other records listing Circulatory Technology, Inc. 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.

K012942THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500K001822THE V-BAGK981284BETTER-BLADDER (BB)K964205BETTER-TUBINGK964337BETTER-BLADDER (BB)K941492PRESSURE RELIEF VALVE

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Related Devices (Code: DWF)

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.

K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.K250937Venous Return CannulaeLivaNova USA, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart ReactorsK253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L.K253998Clearview Intracoronary ShuntsMedtronic, 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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