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FDA 510(k)

BETTER-TUBING

K-Number: K964205 · 1998-04-08

ApplicantCirculatory Technology, Inc.
Decision Date1998-04-08
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BETTER-TUBING 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 1998-04-08 under 510(k) number K964205. 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-TUBING?

BETTER-TUBING is a medical device that received FDA 510(k) clearance on 1998-04-08. The listed applicant is Circulatory Technology, Inc.. The 510(k) number is K964205.

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

BETTER-TUBING received FDA 510(k) clearance on 1998-04-08, under 510(k) number K964205.

Who is the listed applicant for BETTER-TUBING?

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-TUBING?

The FDA product code for BETTER-TUBING 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)K964337BETTER-BLADDER (BB)K961594BETTER-VENTERK941492PRESSURE 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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