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FDA 510(k)

DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD.

K-Number: K905311 · 1991-01-15

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

Device Summary

DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD. 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 K905311. The device is classified under product code DWD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD.?

DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD. 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 K905311.

When did DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD. receive FDA 510(k) clearance?

DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD. received FDA 510(k) clearance on 1991-01-15, under 510(k) number K905311.

Who is the listed applicant for DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD.?

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 SUCTION WANDS VAR. MOD.?

The FDA product code for DURAFLO II HEPARIN TREATED SUCTION WANDS VAR. MOD. is DWD.

Related Clinical Trials

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.

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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.

K905312DURAFLO II HEPARIN TREATED FEMORAL CANNULAE MODELSK882892MEMBRANE OXYGENATOR

Related Devices (Code: DWD)

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.

K992657IBC VRV, MODEL 1350International Biophysics Corp.K920077NIKKISO NK PUMPInternational Medical Products, Inc.K915481B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINTBd Becton Dickinson Vacutainer Systems PreanalyticK915480B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT.Bd Becton Dickinson Vacutainer Systems PreanalyticK915482B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PTBd Becton Dickinson Vacutainer Systems PreanalyticK895427MEDISEAL SUCTION CANISTERDeroyal Industries, 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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