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FDA 510(k)

EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET

K-Number: K881279 · 1988-05-18

ApplicantBaxter Healthcare Corp
Decision Date1988-05-18
Product CodeDTI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1988-05-18 under 510(k) number K881279. The device is classified under product code DTI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET?

EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET is a medical device that received FDA 510(k) clearance on 1988-05-18. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K881279.

When did EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET receive FDA 510(k) clearance?

EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET received FDA 510(k) clearance on 1988-05-18, under 510(k) number K881279.

Who is the listed applicant for EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET?

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

What is the FDA product code for EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET?

The FDA product code for EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET is DTI.

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Other records listing Baxter Healthcare Corp as applicant

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Related Devices (Code: DTI)

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.

K952184CARBOMEDICS SUPRA-ANNULAR VALVE SIZERCarbomedics, Inc.K934951VALVE SIZERCarbomedics, Inc.K853313DUROMEDICS CARDIAC VALVE SIZER SETHemex Scientific, Inc.K852612METRONIC MODEL F7700 HEART VALVE SIZERSMedtronic VascularK820887MITRAL VALVE ORIFICE SIZERCeltechK801885HANCOCK * OBTURATORSHancock Laboratories, 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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