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FDA 510(k)

SHEATH/DILATORS

K-Number: K872724 · 1987-09-15

ApplicantMed-West, Inc.
Decision Date1987-09-15
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SHEATH/DILATORS is the device name listed in this FDA 510(k) record. The listed applicant is Med-West, Inc.. It received FDA 510(k) clearance on 1987-09-15 under 510(k) number K872724. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHEATH/DILATORS?

SHEATH/DILATORS is a medical device that received FDA 510(k) clearance on 1987-09-15. The listed applicant is Med-West, Inc.. The 510(k) number is K872724.

When did SHEATH/DILATORS receive FDA 510(k) clearance?

SHEATH/DILATORS received FDA 510(k) clearance on 1987-09-15, under 510(k) number K872724.

Who is the listed applicant for SHEATH/DILATORS?

The FDA 510(k) record lists Med-West, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHEATH/DILATORS?

The FDA product code for SHEATH/DILATORS is DRE.

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Other records listing Med-West, Inc. as applicant

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Related Devices (Code: DRE)

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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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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