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FDA 510(k)

DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS

K-Number: K905312 · 1991-01-15

ApplicantBaxter Bentley Laboratories, Inc.
Decision Date1991-01-15
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Bentley Laboratories, Inc.. It received FDA 510(k) clearance on 1991-01-15 under 510(k) number K905312. 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 DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS?

DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS is a medical device that received FDA 510(k) clearance on 1991-01-15. The listed applicant is Baxter Bentley Laboratories, Inc.. The 510(k) number is K905312.

When did DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS receive FDA 510(k) clearance?

DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS received FDA 510(k) clearance on 1991-01-15, under 510(k) number K905312.

Who is the listed applicant for DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS?

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

What is the FDA product code for DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS?

The FDA product code for DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELS is DWF.

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Other records listing Baxter Bentley Laboratories, 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.

K905311DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD.K882892MEMBRANE OXYGENATOR

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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