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FDA 510(k)

BAXTER HEMOSTASIS VALVE INTRODUCERS

K-Number: K981909 · 1998-11-24

ApplicantBaxter Edwards
Decision Date1998-11-24
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BAXTER HEMOSTASIS VALVE INTRODUCERS is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Edwards. It received FDA 510(k) clearance on 1998-11-24 under 510(k) number K981909. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAXTER HEMOSTASIS VALVE INTRODUCERS?

BAXTER HEMOSTASIS VALVE INTRODUCERS is a medical device that received FDA 510(k) clearance on 1998-11-24. The listed applicant is Baxter Edwards. The 510(k) number is K981909.

When did BAXTER HEMOSTASIS VALVE INTRODUCERS receive FDA 510(k) clearance?

BAXTER HEMOSTASIS VALVE INTRODUCERS received FDA 510(k) clearance on 1998-11-24, under 510(k) number K981909.

Who is the listed applicant for BAXTER HEMOSTASIS VALVE INTRODUCERS?

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

What is the FDA product code for BAXTER HEMOSTASIS VALVE INTRODUCERS?

The FDA product code for BAXTER HEMOSTASIS VALVE INTRODUCERS is DYB.

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Other records listing Baxter Edwards 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.

K993816BAXTER PERCUTANEOUS MECHANICAL THROMBECTOMY (PMT) DEVICE, MODELS PMT0606FD AND PMT1206FDK980487CARPENTER-EDWARDS CLASSIC RING WITH DURAFLO TREATMENT MODELS 4425 (MITRAL) AND 4525 (TRICUSPID), CARPENTER-EDWARDS PHYSMK965137FOGARTY VALVULOTOME MODEL 700091K964021INTRAMED SIDE BRANCH OCCLUSION (SBO) SYSTEM (700095 AND 700099)K955839MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETERK9526384.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[

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Related Devices (Code: DYB)

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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